Solar™ Interbody Fusion System
Fixed Angle Anterior Lumbar Screw, Self Drilling 5.0x17.5mm
3manufacturers in China registered for this device type
899catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shandong (2), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Degen Medical, United States |
|---|---|
| FDA product code | OVD |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K231199 |
| Record published | 2023-07-15 |
| Record revised | 2024-09-11 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1203-423009L05 | Width (42 Millimeter);Depth (30 Millimeter);Height (9 Millimeter);Lordosis (5 Degrees) | In distribution |
| 1201-382617L30 | Width (38 Millimeter);Depth (26 Millimeter);Height (17 Millimeter);Lordosis (30 Degrees) | In distribution |
| 12-04T402615L20 | Width (40 Millimeter);Depth (26 Millimeter);Height (15 Millimeter);Lordosis (20 Degrees) | In distribution |
| 1203-382612L05 | Width (38 Millimeter);Depth (26 Millimeter);Height (12 Millimeter);Lordosis (5 Degrees) | In distribution |
| 12-04T402818L00 | Width (40 Millimeter);Depth (28 Millimeter);Height (18 Millimeter);Lordosis (0 Degrees) | In distribution |
| 1201-362417L30 | Width (36 Millimeter);Depth (24 Millimeter);Height (17 Millimeter);Lordosis (30 Degrees) | In distribution |
| 12-04T402617L00 | Width (40 Millimeter);Depth (26 Millimeter);Height (17 Millimeter);Lordosis (0 Degrees) | In distribution |
| 12-04T342409L00 | Width (34 Millimeter);Depth (24 Millimeter);Height (9 Millimeter);Lordosis (0 Degrees) | In distribution |
| 1211-5550 | Diameter (5.5 Millimeter);Length (50 Millimeter) | In distribution |
| 1201-402613L05 | Width (40 Millimeter);Depth (26 Millimeter);Height (13 Millimeter);Lordosis (5 Degrees) | In distribution |
| 12-04T322412L10 | Width (32 Millimeter);Depth (24 Millimeter);Height (12 Millimeter);Lordosis (10 Degrees) | In distribution |
| 1206-5055 | Diameter (5.0 Millimeter);Length (55 Millimeter) | In distribution |
| 1203-382821L25 | Width (38 Millimeter);Depth (28 Millimeter);Height (21 Millimeter);Lordosis (25 Degrees) | In distribution |
| 1203-362413L00 | Width (36 Millimeter);Depth (24 Millimeter);Height (13 Millimeter);Lordosis (0 Degrees) | In distribution |
| 1203-342414L25 | Width (34 Millimeter);Depth (24 Millimeter);Height (14 Millimeter);Lordosis (25 Degrees) | In distribution |
| 1202-402813L05 | Width (40 Millimeter);Depth (28 Millimeter);Height (13 Millimeter);Lordosis (5 Degrees) | In distribution |
| 1201-342613L00 | Width (34 Millimeter);Depth (26 Millimeter);Height (13 Millimeter);Lordosis (0 Degrees) | In distribution |
| 1203-402609L05 | Width (40 Millimeter);Depth (26 Millimeter);Height (9 Millimeter);Lordosis (5 Degrees) | In distribution |
| 1203-342411L15 | Width (34 Millimeter);Depth (24 Millimeter);Height (11 Millimeter);Lordosis (15 Degrees) | In distribution |
| 1206-5028 | Diameter (5.0 Millimeter);Length (28 Millimeter) | In distribution |
| 1201-362612L10 | Width (36 Millimeter);Depth (26 Millimeter);Height (12 Millimeter);Lordosis (10 Degrees) | In distribution |
| 1203-342413L10 | Width (34 Millimeter);Depth (24 Millimeter);Height (13 Millimeter);Lordosis (10 Degrees) | In distribution |
| 12-04T342619L25 | Width (34 Millimeter);Depth (26 Millimeter);Height (19 Millimeter);Lordosis (25 Degrees) | In distribution |
| 1201-382813L15 | Width (38 Millimeter);Depth (28 Millimeter);Height (13 Millimeter);Lordosis (15 Degrees) | In distribution |
| 1203-382610L05 | Width (38 Millimeter);Depth (26 Millimeter);Height (10 Millimeter);Lordosis (5 Degrees) | In distribution |
| 12-04T402821L25 | Width (40 Millimeter);Depth (28 Millimeter);Height (21 Millimeter);Lordosis (25 Degrees) | In distribution |
| 1201-342420L00 | Width (34 Millimeter);Depth (24 Millimeter);Height (20 Millimeter);Lordosis (0 Degrees) | In distribution |
| 1203-362414L05 | Width (36 Millimeter);Depth (24 Millimeter);Height (14 Millimeter);Lordosis (5 Degrees) | In distribution |
| 1201-362618L30 | Width (36 Millimeter);Depth (26 Millimeter);Height (18 Millimeter);Lordosis (30 Degrees) | In distribution |
| 1203-322417L10 | Width (32 Millimeter);Depth (24 Millimeter);Height (17 Millimeter);Lordosis (10 Degrees) | In distribution |
| 1203-322416L20 | Width (32 Millimeter);Depth (24 Millimeter);Height (16 Millimeter);Lordosis (20 Degrees) | In distribution |
| 1203-362619L15 | Width (36 Millimeter);Depth (26 Millimeter);Height (19 Millimeter);Lordosis (15 Degrees) | In distribution |
| 12-04T342415L05 | Width (34 Millimeter);Depth (24 Millimeter);Height (15 Millimeter);Lordosis (5 Degrees) | In distribution |
| 12-04T342613L15 | Width (34 Millimeter);Depth (26 Millimeter);Height (13 Millimeter);Lordosis (15 Degrees) | In distribution |
| 1203-402621L10 | Width (40 Millimeter);Depth (26 Millimeter);Height (21 Millimeter);Lordosis (10 Degrees) | In distribution |
| 1201-362615L05 | Width (36 Millimeter);Depth (26 Millimeter);Height (15 Millimeter);Lordosis (5 Degrees) | In distribution |
| 12-04T322421L25 | Width (32 Millimeter);Depth (24 Millimeter);Height (21 Millimeter);Lordosis (25 Degrees) | In distribution |
| 12-04T342414L10 | Width (34 Millimeter);Depth (24 Millimeter);Height (14 Millimeter);Lordosis (10 Degrees) | In distribution |
| 1203-402819L10 | Width (40 Millimeter);Depth (28 Millimeter);Height (19 Millimeter);Lordosis (10 Degrees) | In distribution |
| 1202-322412L00 | Width (32 Millimeter);Depth (24 Millimeter);Height (12 Millimeter);Lordosis (0 Degrees) | In distribution |
| 1201-382817L20 | Width (38 Millimeter);Depth (28 Millimeter);Height (17 Millimeter);Lordosis (20 Degrees) | In distribution |
| 1203-422815L20 | Width (42 Millimeter);Depth (28 Millimeter);Height (15 Millimeter);Lordosis (20 Degrees) | In distribution |
| 1203-382820L00 | Width (38 Millimeter);Depth (28 Millimeter);Height (20 Millimeter);Lordosis (0 Degrees) | In distribution |
| 1202-362621L25 | Width (36 Millimeter);Depth (26 Millimeter);Height (21 Millimeter);Lordosis (25 Degrees) | In distribution |
| 1201-342619L25 | Width (34 Millimeter);Depth (26 Millimeter);Height (19 Millimeter);Lordosis (25 Degrees) | In distribution |
| 1203-382819L00 | Width (38 Millimeter);Depth (28 Millimeter);Height (19 Millimeter);Lordosis (0 Degrees) | In distribution |
| 12-04T362611L10 | Width (36 Millimeter);Depth (26 Millimeter);Height (11 Millimeter);Lordosis (10 Degrees) | In distribution |
| 1201-342617L30 | Width (34 Millimeter);Depth (26 Millimeter);Height (17 Millimeter);Lordosis (30 Degrees) | In distribution |
| 1203-362420L25 | Width (36 Millimeter);Depth (24 Millimeter);Height (20 Millimeter);Lordosis (25 Degrees) | In distribution |
| 1205-5025 | Diameter (5.0 Millimeter);Length (25 Millimeter) | In distribution |
| 1201-402821L05 | Width (40 Millimeter);Depth (28 Millimeter);Height (21 Millimeter);Lordosis (5 Degrees) | In distribution |
| 1201-423015L15 | Width (42 Millimeter);Depth (30 Millimeter);Height (15 Millimeter);Lordosis (15 Degrees) | In distribution |
| 1201-402817L10 | Width (40 Millimeter);Depth (28 Millimeter);Height (17 Millimeter);Lordosis (10 Degrees) | In distribution |
| 1203-423021L15 | Width (42 Millimeter);Depth (30 Millimeter);Height (21 Millimeter);Lordosis (15 Degrees) | In distribution |
| 1201-402617L05 | Width (40 Millimeter);Depth (26 Millimeter);Height (17 Millimeter);Lordosis (5 Degrees) | In distribution |
| 1201-402812L00 | Width (40 Millimeter);Depth (28 Millimeter);Height (12 Millimeter);Lordosis (0 Degrees) | In distribution |
| 1201-382619L25 | Width (38 Millimeter);Depth (26 Millimeter);Height (19 Millimeter);Lordosis (25 Degrees) | In distribution |
| 12-04T423017L15 | Width (42 Millimeter);Depth (30 Millimeter);Height (17 Millimeter);Lordosis (15 Degrees) | In distribution |
| 1201-402820L15 | Width (40 Millimeter);Depth (28 Millimeter);Height (20 Millimeter);Lordosis (15 Degrees) | In distribution |
| 1203-422821L00 | Width (42 Millimeter);Depth (28 Millimeter);Height (21 Millimeter);Lordosis (0 Degrees) | In distribution |
| 1203-362612L15 | Width (36 Millimeter);Depth (26 Millimeter);Height (12 Millimeter);Lordosis (15 Degrees) | In distribution |
| 1202-423019L25 | Width (42 Millimeter);Depth (30 Millimeter);Height (19 Millimeter);Lordosis (25 Degrees) | In distribution |
| 1203-422821L10 | Width (42 Millimeter);Depth (28 Millimeter);Height (21 Millimeter);Lordosis (10 Degrees) | In distribution |
| 12-04T362415L15 | Width (36 Millimeter);Depth (24 Millimeter);Height (15 Millimeter);Lordosis (15 Degrees) | In distribution |
| 1203-422819L25 | Width (42 Millimeter);Depth (28 Millimeter);Height (19 Millimeter);Lordosis (25 Degrees) | In distribution |
| 1204-5517 | Diameter (5.5 Millimeter);Length (17.5 Millimeter) | In distribution |
| 1210-5528 | Diameter (5.5 Millimeter);Length (28 Millimeter) | In distribution |
| 1201-382815L15 | Width (38 Millimeter);Depth (28 Millimeter);Height (15 Millimeter);Lordosis (15 Degrees) | In distribution |
| 12-04T342418L15 | Width (34 Millimeter);Depth (24 Millimeter);Height (18 Millimeter);Lordosis (15 Degrees) | In distribution |
| 1201-382613L20 | Width (38 Millimeter);Depth (26 Millimeter);Height (13 Millimeter);Lordosis (20 Degrees) | In distribution |
| 1203-382620L10 | Width (38 Millimeter);Depth (26 Millimeter);Height (20 Millimeter);Lordosis (10 Degrees) | In distribution |
| 1201-362418L10 | Width (36 Millimeter);Depth (24 Millimeter);Height (18 Millimeter);Lordosis (10 Degrees) | In distribution |
| 12-04T362615L20 | Width (36 Millimeter);Depth (26 Millimeter);Height (15 Millimeter);Lordosis (20 Degrees) | In distribution |
| 12-04T402821L30 | Width (40 Millimeter);Depth (28 Millimeter);Height (21 Millimeter);Lordosis (30 Degrees) | In distribution |
| 1203-423013L15 | Width (42 Millimeter);Depth (30 Millimeter);Height (13 Millimeter);Lordosis (15 Degrees) | In distribution |
| 1203-362412L15 | Width (36 Millimeter);Depth (24 Millimeter);Height (12 Millimeter);Lordosis (15 Degrees) | In distribution |
| 12-04T322410L00 | Width (32 Millimeter);Depth (24 Millimeter);Height (10 Millimeter);Lordosis (0 Degrees) | In distribution |
| 1201-402816L20 | Width (40 Millimeter);Depth (28 Millimeter);Height (16 Millimeter);Lordosis (20 Degrees) | In distribution |
| 1203-402813L15 | Width (40 Millimeter);Depth (28 Millimeter);Height (13 Millimeter);Lordosis (15 Degrees) | In distribution |
| 1203-342419L05 | Width (34 Millimeter);Depth (24 Millimeter);Height (19 Millimeter);Lordosis (5 Degrees) | In distribution |
| 12-04T362611L15 | Width (36 Millimeter);Depth (26 Millimeter);Height (11 Millimeter);Lordosis (15 Degrees) | In distribution |
| 1202-322415L05 | Width (32 Millimeter);Depth (24 Millimeter);Height (15 Millimeter);Lordosis (5 Degrees) | In distribution |
| 1202-322421L15 | Width (32 Millimeter);Depth (24 Millimeter);Height (21 Millimeter);Lordosis (15 Degrees) | In distribution |
| 1203-423011L15 | Width (42 Millimeter);Depth (30 Millimeter);Height (11 Millimeter);Lordosis (15 Degrees) | In distribution |
| 1201-322414L20 | Width (32 Millimeter);Depth (24 Millimeter);Height (14 Millimeter);Lordosis (20 Degrees) | In distribution |
| 12-04T402813L20 | Width (40 Millimeter);Depth (28 Millimeter);Height (13 Millimeter);Lordosis (20 Degrees) | In distribution |
| 1203-382813L05 | Width (38 Millimeter);Depth (28 Millimeter);Height (13 Millimeter);Lordosis (5 Degrees) | In distribution |
| 12-04T362618L30 | Width (36 Millimeter);Depth (26 Millimeter);Height (18 Millimeter);Lordosis (30 Degrees) | In distribution |
| 1205-5540 | Diameter (5.5 Millimeter);Length (40 Millimeter) | In distribution |
| 12-04T322409L05 | Width (32 Millimeter);Depth (24 Millimeter);Height (9 Millimeter);Lordosis (5 Degrees) | In distribution |
| 1203-402611L10 | Width (40 Millimeter);Depth (26 Millimeter);Height (11 Millimeter);Lordosis (10 Degrees) | In distribution |
| 1201-362611L10 | Width (36 Millimeter);Depth (26 Millimeter);Height (11 Millimeter);Lordosis (10 Degrees) | In distribution |
| 12-04T402613L10 | Width (40 Millimeter);Depth (26 Millimeter);Height (13 Millimeter);Lordosis (10 Degrees) | In distribution |
| 1201-382817L05 | Width (38 Millimeter);Depth (28 Millimeter);Height (17 Millimeter);Lordosis (5 Degrees) | In distribution |
| 1203-322418L00 | Width (32 Millimeter);Depth (24 Millimeter);Height (18 Millimeter);Lordosis (0 Degrees) | In distribution |
| 12-04T402810L00 | Width (40 Millimeter);Depth (28 Millimeter);Height (10 Millimeter);Lordosis (0 Degrees) | In distribution |
| 1203-342409L00 | Width (34 Millimeter);Depth (24 Millimeter);Height (9 Millimeter);Lordosis (0 Degrees) | In distribution |
| 1203-362614L20 | Width (36 Millimeter);Depth (26 Millimeter);Height (14 Millimeter);Lordosis (20 Degrees) | In distribution |
| 1203-402810L05 | Width (40 Millimeter);Depth (28 Millimeter);Height (10 Millimeter);Lordosis (5 Degrees) | In distribution |
| 12-04T342618L05 | Width (34 Millimeter);Depth (26 Millimeter);Height (18 Millimeter);Lordosis (5 Degrees) | In distribution |
| 1201-342617L25 | Width (34 Millimeter);Depth (26 Millimeter);Height (17 Millimeter);Lordosis (25 Degrees) | In distribution |
| 1203-423015L15 | Width (42 Millimeter);Depth (30 Millimeter);Height (15 Millimeter);Lordosis (15 Degrees) | In distribution |
| 1202-322421L25 | Width (32 Millimeter);Depth (24 Millimeter);Height (21 Millimeter);Lordosis (25 Degrees) | In distribution |
| 12-04T402618L20 | Width (40 Millimeter);Depth (26 Millimeter);Height (18 Millimeter);Lordosis (20 Degrees) | In distribution |
| 1203-362417L00 | Width (36 Millimeter);Depth (24 Millimeter);Height (17 Millimeter);Lordosis (0 Degrees) | In distribution |
| 1202-402812L15 | Width (40 Millimeter);Depth (28 Millimeter);Height (12 Millimeter);Lordosis (15 Degrees) | In distribution |
| 12-04T322419L30 | Width (32 Millimeter);Depth (24 Millimeter);Height (19 Millimeter);Lordosis (30 Degrees) | In distribution |
| 1203-362418L10 | Width (36 Millimeter);Depth (24 Millimeter);Height (18 Millimeter);Lordosis (10 Degrees) | In distribution |
| 1203-362416L00 | Width (36 Millimeter);Depth (24 Millimeter);Height (16 Millimeter);Lordosis (0 Degrees) | In distribution |
| 1203-402610L15 | Width (40 Millimeter);Depth (26 Millimeter);Height (10 Millimeter);Lordosis (15 Degrees) | In distribution |
| 12-04T342416L15 | Width (34 Millimeter);Depth (24 Millimeter);Height (16 Millimeter);Lordosis (15 Degrees) | In distribution |
| 12-04T382817L05 | Width (38 Millimeter);Depth (28 Millimeter);Height (17 Millimeter);Lordosis (5 Degrees) | In distribution |
| 1201-382621L25 | Width (38 Millimeter);Depth (26 Millimeter);Height (21 Millimeter);Lordosis (25 Degrees) | In distribution |
| 1203-402611L00 | Width (40 Millimeter);Depth (26 Millimeter);Height (11 Millimeter);Lordosis (0 Degrees) | In distribution |
| 12-04T422816L25 | Width (42 Millimeter);Depth (28 Millimeter);Height (16 Millimeter);Lordosis (25 Degrees) | In distribution |
| 1201-382613L10 | Width (38 Millimeter);Depth (26 Millimeter);Height (13 Millimeter);Lordosis (10 Degrees) | In distribution |
| 1201-322417L15 | Width (32 Millimeter);Depth (24 Millimeter);Height (17 Millimeter);Lordosis (15 Degrees) | In distribution |
| 1202-423019L00 | Width (42 Millimeter);Depth (30 Millimeter);Height (19 Millimeter);Lordosis (0 Degrees) | In distribution |
| 1201-362615L20 | Width (36 Millimeter);Depth (26 Millimeter);Height (15 Millimeter);Lordosis (20 Degrees) | In distribution |
| 1210-5025 | Diameter (5.0 Millimeter);Length (25 Millimeter) | In distribution |
| 1203-362619L30 | Width (36 Millimeter);Depth (26 Millimeter);Height (19 Millimeter);Lordosis (30 Degrees) | In distribution |
| 1201-382618L30 | Width (38 Millimeter);Depth (26 Millimeter);Height (18 Millimeter);Lordosis (30 Degrees) | In distribution |
| 1203-382817L05 | Width (38 Millimeter);Depth (28 Millimeter);Height (17 Millimeter);Lordosis (5 Degrees) | In distribution |
| 1203-362609L10 | Width (36 Millimeter);Depth (26 Millimeter);Height (9 Millimeter);Lordosis (10 Degrees) | In distribution |
| 1201-322418L10 | Width (32 Millimeter);Depth (24 Millimeter);Height (18 Millimeter);Lordosis (10 Degrees) | In distribution |
| 1201-382621L15 | Width (38 Millimeter);Depth (26 Millimeter);Height (21 Millimeter);Lordosis (15 Degrees) | In distribution |
| 1203-422814L00 | Width (42 Millimeter);Depth (28 Millimeter);Height (14 Millimeter);Lordosis (0 Degrees) | In distribution |
| 1203-362609L05 | Width (36 Millimeter);Depth (26 Millimeter);Height (9 Millimeter);Lordosis (5 Degrees) | In distribution |
| 1206-5035 | Diameter (5.0 Millimeter);Length (35 Millimeter) | In distribution |
| 1203-342620L00 | Width (34 Millimeter);Depth (26 Millimeter);Height (20 Millimeter);Lordosis (0 Degrees) | In distribution |
| 1203-382816L25 | Width (38 Millimeter);Depth (28 Millimeter);Height (16 Millimeter);Lordosis (25 Degrees) | In distribution |
| 1203-362619L10 | Width (36 Millimeter);Depth (26 Millimeter);Height (19 Millimeter);Lordosis (10 Degrees) | In distribution |
| 1201-422816L00 | Width (42 Millimeter);Depth (28 Millimeter);Height (16 Millimeter);Lordosis (0 Degrees) | In distribution |
| 1201-422813L15 | Width (42 Millimeter);Depth (28 Millimeter);Height (13 Millimeter);Lordosis (15 Degrees) | In distribution |
| 12-04T402810L10 | Width (40 Millimeter);Depth (28 Millimeter);Height (10 Millimeter);Lordosis (10 Degrees) | In distribution |
| 12-04T362412L10 | Width (36 Millimeter);Depth (24 Millimeter);Height (12 Millimeter);Lordosis (10 Degrees) | In distribution |
| 12-04T362617L05 | Width (36 Millimeter);Depth (26 Millimeter);Height (17 Millimeter);Lordosis (5 Degrees) | In distribution |
| 1203-362616L00 | Width (36 Millimeter);Depth (26 Millimeter);Height (16 Millimeter);Lordosis (0 Degrees) | In distribution |
| 1201-382616L10 | Width (38 Millimeter);Depth (26 Millimeter);Height (16 Millimeter);Lordosis (10 Degrees) | In distribution |
| 1203-423018L25 | Width (42 Millimeter);Depth (30 Millimeter);Height (18 Millimeter);Lordosis (25 Degrees) | In distribution |
| 12-04T362610L05 | Width (36 Millimeter);Depth (26 Millimeter);Height (10 Millimeter);Lordosis (5 Degrees) | In distribution |
| 12-04T422814L00 | Width (42 Millimeter);Depth (28 Millimeter);Height (14 Millimeter);Lordosis (0 Degrees) | In distribution |
| 12-04T423015L20 | Width (42 Millimeter);Depth (30 Millimeter);Height (15 Millimeter);Lordosis (20 Degrees) | In distribution |
| 1201-382819L20 | Width (38 Millimeter);Depth (28 Millimeter);Height (19 Millimeter);Lordosis (20 Degrees) | In distribution |
| 12-04T382809L00 | Width (38 Millimeter);Depth (28 Millimeter);Height (9 Millimeter);Lordosis (0 Degrees) | In distribution |
| 12-04T422817L25 | Width (42 Millimeter);Depth (28 Millimeter);Height (17 Millimeter);Lordosis (25 Degrees) | In distribution |
| 12-04T422815L05 | Width (42 Millimeter);Depth (28 Millimeter);Height (15 Millimeter);Lordosis (5 Degrees) | In distribution |
| 1203-402820L00 | Width (40 Millimeter);Depth (28 Millimeter);Height (20 Millimeter);Lordosis (0 Degrees) | In distribution |
| 12-04T362420L00 | Width (36 Millimeter);Depth (24 Millimeter);Height (20 Millimeter);Lordosis (0 Degrees) | In distribution |
| 1201-402814L00 | Width (40 Millimeter);Depth (28 Millimeter);Height (14 Millimeter);Lordosis (0 Degrees) | In distribution |
| 1203-322417L20 | Width (32 Millimeter);Depth (24 Millimeter);Height (17 Millimeter);Lordosis (20 Degrees) | In distribution |
| 1201-402620L00 | Width (40 Millimeter);Depth (26 Millimeter);Height (20 Millimeter);Lordosis (0 Degrees) | In distribution |
| 1203-342611L00 | Width (34 Millimeter);Depth (26 Millimeter);Height (11 Millimeter);Lordosis (0 Degrees) | In distribution |
| 1203-362421L20 | Width (36 Millimeter);Depth (24 Millimeter);Height (21 Millimeter);Lordosis (20 Degrees) | In distribution |
| 12-04T402614L05 | Width (40 Millimeter);Depth (26 Millimeter);Height (14 Millimeter);Lordosis (5 Degrees) | In distribution |
| 12-04T342412L10 | Width (34 Millimeter);Depth (24 Millimeter);Height (12 Millimeter);Lordosis (10 Degrees) | In distribution |
| 1203-362411L10 | Width (36 Millimeter);Depth (24 Millimeter);Height (11 Millimeter);Lordosis (10 Degrees) | In distribution |
| 1202-402812L05 | Width (40 Millimeter);Depth (28 Millimeter);Height (12 Millimeter);Lordosis (5 Degrees) | In distribution |
| 12-04T382811L15 | Width (38 Millimeter);Depth (28 Millimeter);Height (11 Millimeter);Lordosis (15 Degrees) | In distribution |
| 1203-342616L15 | Width (34 Millimeter);Depth (26 Millimeter);Height (16 Millimeter);Lordosis (15 Degrees) | In distribution |
| 1204-5540 | Diameter (5.5 Millimeter);Length (40 Millimeter) | In distribution |
| 1201-322414L00 | Width (32 Millimeter);Depth (24 Millimeter);Height (14 Millimeter);Lordosis (0 Degrees) | In distribution |
| 12-04T342615L10 | Width (34 Millimeter);Depth (26 Millimeter);Height (15 Millimeter);Lordosis (10 Degrees) | In distribution |
| 1203-362418L05 | Width (36 Millimeter);Depth (24 Millimeter);Height (18 Millimeter);Lordosis (5 Degrees) | In distribution |
| 1203-362412L05 | Width (36 Millimeter);Depth (24 Millimeter);Height (12 Millimeter);Lordosis (5 Degrees) | In distribution |
| 1203-342615L00 | Width (34 Millimeter);Depth (26 Millimeter);Height (15 Millimeter);Lordosis (0 Degrees) | In distribution |
| 12-04T422820L10 | Width (42 Millimeter);Depth (28 Millimeter);Height (20 Millimeter);Lordosis (10 Degrees) | In distribution |
| 12-04T362617L20 | Width (36 Millimeter);Depth (26 Millimeter);Height (17 Millimeter);Lordosis (20 Degrees) | In distribution |
| 1203-342610L00 | Width (34 Millimeter);Depth (26 Millimeter);Height (10 Millimeter);Lordosis (0 Degrees) | In distribution |
| 1201-322420L00 | Width (32 Millimeter);Depth (24 Millimeter);Height (20 Millimeter);Lordosis (0 Degrees) | In distribution |
| 1201-402820L30 | Width (40 Millimeter);Depth (28 Millimeter);Height (20 Millimeter);Lordosis (30 Degrees) | In distribution |
| 1201-362620L30 | Width (36 Millimeter);Depth (26 Millimeter);Height (20 Millimeter);Lordosis (30 Degrees) | In distribution |
| 12-04T362415L25 | Width (36 Millimeter);Depth (24 Millimeter);Height (15 Millimeter);Lordosis (25 Degrees) | In distribution |
| 1203-423020L10 | Width (42 Millimeter);Depth (30 Millimeter);Height (20 Millimeter);Lordosis (10 Degrees) | In distribution |
| 1203-362617L00 | Width (36 Millimeter);Depth (26 Millimeter);Height (17 Millimeter);Lordosis (0 Degrees) | In distribution |
| 1201-322419L05 | Width (32 Millimeter);Depth (24 Millimeter);Height (19 Millimeter);Lordosis (5 Degrees) | In distribution |
| 12-04T362418L05 | Width (36 Millimeter);Depth (24 Millimeter);Height (18 Millimeter);Lordosis (5 Degrees) | In distribution |
| 12-04T423014L05 | Width (42 Millimeter);Depth (30 Millimeter);Height (14 Millimeter);Lordosis (5 Degrees) | In distribution |
| 1205-5535 | Diameter (5.5 Millimeter);Length (35 Millimeter) | In distribution |
| 12-04T342609L10 | Width (34 Millimeter);Depth (26 Millimeter);Height (9 Millimeter);Lordosis (10 Degrees) | In distribution |
| 1203-322413L15 | Width (32 Millimeter);Depth (24 Millimeter);Height (13 Millimeter);Lordosis (15 Degrees) | In distribution |
| 1202-322415L20 | Width (32 Millimeter);Depth (24 Millimeter);Height (15 Millimeter);Lordosis (20 Degrees) | In distribution |
| 1203-382817L10 | Width (38 Millimeter);Depth (28 Millimeter);Height (17 Millimeter);Lordosis (10 Degrees) | In distribution |
| 1201-362619L15 | Width (36 Millimeter);Depth (26 Millimeter);Height (19 Millimeter);Lordosis (15 Degrees) | In distribution |
| 1203-362421L30 | Width (36 Millimeter);Depth (24 Millimeter);Height (21 Millimeter);Lordosis (30 Degrees) | In distribution |
| 1201-423020L25 | Width (42 Millimeter);Depth (30 Millimeter);Height (20 Millimeter);Lordosis (25 Degrees) | In distribution |
| 12-04T382618L10 | Width (38 Millimeter);Depth (26 Millimeter);Height (18 Millimeter);Lordosis (10 Degrees) | In distribution |
| 1201-402620L20 | Width (40 Millimeter);Depth (26 Millimeter);Height (20 Millimeter);Lordosis (20 Degrees) | In distribution |
| 1203-362420L10 | Width (36 Millimeter);Depth (24 Millimeter);Height (20 Millimeter);Lordosis (10 Degrees) | In distribution |
| 1203-362421L05 | Width (36 Millimeter);Depth (24 Millimeter);Height (21 Millimeter);Lordosis (5 Degrees) | In distribution |
| 12-04T362616L05 | Width (36 Millimeter);Depth (26 Millimeter);Height (16 Millimeter);Lordosis (5 Degrees) | In distribution |
| 12-04T423014L10 | Width (42 Millimeter);Depth (30 Millimeter);Height (14 Millimeter);Lordosis (10 Degrees) | In distribution |
| 1201-342616L15 | Width (34 Millimeter);Depth (26 Millimeter);Height (16 Millimeter);Lordosis (15 Degrees) | In distribution |
| 1201-423017L00 | Width (42 Millimeter);Depth (30 Millimeter);Height (17 Millimeter);Lordosis (0 Degrees) | In distribution |
| 1203-342620L05 | Width (34 Millimeter);Depth (26 Millimeter);Height (20 Millimeter);Lordosis (5 Degrees) | In distribution |
| 1203-322409L10 | Width (32 Millimeter);Depth (24 Millimeter);Height (9 Millimeter);Lordosis (10 Degrees) | In distribution |
| 1203-422815L10 | Width (42 Millimeter);Depth (28 Millimeter);Height (15 Millimeter);Lordosis (10 Degrees) | In distribution |
| 12-04T402621L30 | Width (40 Millimeter);Depth (26 Millimeter);Height (21 Millimeter);Lordosis (30 Degrees) | In distribution |
| 1201-342415L20 | Width (34 Millimeter);Depth (24 Millimeter);Height (15 Millimeter);Lordosis (20 Degrees) | In distribution |
| 1203-342613L10 | Width (34 Millimeter);Depth (26 Millimeter);Height (13 Millimeter);Lordosis (10 Degrees) | In distribution |
| 12-04T402617L25 | Width (40 Millimeter);Depth (26 Millimeter);Height (17 Millimeter);Lordosis (25 Degrees) | In distribution |
| 1202-362612L05 | Width (36 Millimeter);Depth (26 Millimeter);Height (12 Millimeter);Lordosis (5 Degrees) | In distribution |
| 1203-422816L05 | Width (42 Millimeter);Depth (28 Millimeter);Height (16 Millimeter);Lordosis (5 Degrees) | In distribution |
| 1201-322418L15 | Width (32 Millimeter);Depth (24 Millimeter);Height (18 Millimeter);Lordosis (15 Degrees) | In distribution |
| 1201-362621L10 | Width (36 Millimeter);Depth (26 Millimeter);Height (21 Millimeter);Lordosis (10 Degrees) | In distribution |
| 1210-5522 | Diameter (5.5 Millimeter);Length (22 Millimeter) | In distribution |
| 1201-402818L05 | Width (40 Millimeter);Depth (28 Millimeter);Height (18 Millimeter);Lordosis (5 Degrees) | In distribution |
| 1201-342414L05 | Width (34 Millimeter);Depth (24 Millimeter);Height (14 Millimeter);Lordosis (5 Degrees) | In distribution |
| 1211-5520 | Diameter (5.5 Millimeter);Length (20 Millimeter) | In distribution |
| 12-04T402620L10 | Width (40 Millimeter);Depth (26 Millimeter);Height (20 Millimeter);Lordosis (10 Degrees) | In distribution |
| 12-04T322420L30 | Width (32 Millimeter);Depth (24 Millimeter);Height (20 Millimeter);Lordosis (30 Degrees) | In distribution |
| 1201-402813L05 | Width (40 Millimeter);Depth (28 Millimeter);Height (13 Millimeter);Lordosis (5 Degrees) | In distribution |
| 1201-342619L05 | Width (34 Millimeter);Depth (26 Millimeter);Height (19 Millimeter);Lordosis (5 Degrees) | In distribution |
| 1201-362421L25 | Width (36 Millimeter);Depth (24 Millimeter);Height (21 Millimeter);Lordosis (25 Degrees) | In distribution |
| 1202-402817L25 | Width (40 Millimeter);Depth (28 Millimeter);Height (17 Millimeter);Lordosis (25 Degrees) | In distribution |
| 1203-342417L30 | Width (34 Millimeter);Depth (24 Millimeter);Height (17 Millimeter);Lordosis (30 Degrees) | In distribution |
| 1211-5528 | Diameter (5.5 Millimeter);Length (28 Millimeter) | In distribution |
| 12-04T382621L15 | Width (38 Millimeter);Depth (26 Millimeter);Height (21 Millimeter);Lordosis (15 Degrees) | In distribution |
| 1201-382613L00 | Width (38 Millimeter);Depth (26 Millimeter);Height (13 Millimeter);Lordosis (0 Degrees) | In distribution |
| 1203-362617L20 | Width (36 Millimeter);Depth (26 Millimeter);Height (17 Millimeter);Lordosis (20 Degrees) | In distribution |
| 12-04T382821L25 | Width (38 Millimeter);Depth (28 Millimeter);Height (21 Millimeter);Lordosis (25 Degrees) | In distribution |
| 1203-362417L05 | Width (36 Millimeter);Depth (24 Millimeter);Height (17 Millimeter);Lordosis (5 Degrees) | In distribution |
| 1201-402615L25 | Width (40 Millimeter);Depth (26 Millimeter);Height (15 Millimeter);Lordosis (25 Degrees) | In distribution |
| 1203-342620L20 | Width (34 Millimeter);Depth (26 Millimeter);Height (20 Millimeter);Lordosis (20 Degrees) | In distribution |
| 1203-342420L20 | Width (34 Millimeter);Depth (24 Millimeter);Height (20 Millimeter);Lordosis (20 Degrees) | In distribution |
| 1201-402812L05 | Width (40 Millimeter);Depth (28 Millimeter);Height (12 Millimeter);Lordosis (5 Degrees) | In distribution |
| 1201-342418L10 | Width (34 Millimeter);Depth (24 Millimeter);Height (18 Millimeter);Lordosis (10 Degrees) | In distribution |
| 1202-423019L20 | Width (42 Millimeter);Depth (30 Millimeter);Height (19 Millimeter);Lordosis (20 Degrees) | In distribution |
| 1201-382818L25 | Width (38 Millimeter);Depth (28 Millimeter);Height (18 Millimeter);Lordosis (25 Degrees) | In distribution |
| 1203-423019L00 | Width (42 Millimeter);Depth (30 Millimeter);Height (19 Millimeter);Lordosis (0 Degrees) | In distribution |
| 1201-382816L15 | Width (38 Millimeter);Depth (28 Millimeter);Height (16 Millimeter);Lordosis (15 Degrees) | In distribution |
| 1201-362617L15 | Width (36 Millimeter);Depth (26 Millimeter);Height (17 Millimeter);Lordosis (15 Degrees) | In distribution |
| 1201-362419L10 | Width (36 Millimeter);Depth (24 Millimeter);Height (19 Millimeter);Lordosis (10 Degrees) | In distribution |
| 1203-362415L20 | Width (36 Millimeter);Depth (24 Millimeter);Height (15 Millimeter);Lordosis (20 Degrees) | In distribution |
| 12-04T342614L05 | Width (34 Millimeter);Depth (26 Millimeter);Height (14 Millimeter);Lordosis (5 Degrees) | In distribution |
| 1201-362613L15 | Width (36 Millimeter);Depth (26 Millimeter);Height (13 Millimeter);Lordosis (15 Degrees) | In distribution |
| 1203-422819L00 | Width (42 Millimeter);Depth (28 Millimeter);Height (19 Millimeter);Lordosis (0 Degrees) | In distribution |
| 1201-362417L20 | Width (36 Millimeter);Depth (24 Millimeter);Height (17 Millimeter);Lordosis (20 Degrees) | In distribution |
| 1203-322415L10 | Width (32 Millimeter);Depth (24 Millimeter);Height (15 Millimeter);Lordosis (10 Degrees) | In distribution |
| 12-04T362620L25 | Width (36 Millimeter);Depth (26 Millimeter);Height (20 Millimeter);Lordosis (25 Degrees) | In distribution |
| 1203-382810L00 | Width (38 Millimeter);Depth (28 Millimeter);Height (10 Millimeter);Lordosis (0 Degrees) | In distribution |
| 1201-362621L15 | Width (36 Millimeter);Depth (26 Millimeter);Height (21 Millimeter);Lordosis (15 Degrees) | In distribution |
| 12-04T402819L20 | Width (40 Millimeter);Depth (28 Millimeter);Height (19 Millimeter);Lordosis (20 Degrees) | In distribution |
| 12-04T322413L15 | Width (32 Millimeter);Depth (24 Millimeter);Height (13 Millimeter);Lordosis (15 Degrees) | In distribution |
| 12-04T423015L15 | Width (42 Millimeter);Depth (30 Millimeter);Height (15 Millimeter);Lordosis (15 Degrees) | In distribution |
| 1203-422811L05 | Width (42 Millimeter);Depth (28 Millimeter);Height (11 Millimeter);Lordosis (5 Degrees) | In distribution |
| 1201-362617L30 | Width (36 Millimeter);Depth (26 Millimeter);Height (17 Millimeter);Lordosis (30 Degrees) | In distribution |
| 1201-402611L05 | Width (40 Millimeter);Depth (26 Millimeter);Height (11 Millimeter);Lordosis (5 Degrees) | In distribution |
| 12-04T322419L05 | Width (32 Millimeter);Depth (24 Millimeter);Height (19 Millimeter);Lordosis (5 Degrees) | In distribution |
| 12-04T402819L00 | Width (40 Millimeter);Depth (28 Millimeter);Height (19 Millimeter);Lordosis (0 Degrees) | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sirion | Astura Medical | 1,465 |
| IdentiTi | Alphatec Spine, Inc. | 1,372 |
| EL Capitan | Astura Medical | 1,205 |
| Zavation | Zavation | 1,157 |
| Brigade | Nuvasive, Inc. | 1,005 |
| Zavation F3D Corpectomy | Zavation | 730 |
| ROI-A | Ldr Spine USA | 552 |
| Avenue L | Ldr Spine USA | 524 |
| Transcend Nanotec | Alphatec Spine, Inc. | 485 |
| Endoskeleton® TL Hyperlordotic nanoLOCK® Surface Technology | Titan Spine, LLC | 462 |
| Base | Nuvasive, Inc. | 462 |
| IDENTITi Nanotec | Alphatec Spine, Inc. | 453 |
Showing 12 of 241. All products under Intervertebral Fusion Device With Integrated Fixation, Lumbar
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251829 | 2025-12-08 |
| K241077 | 2024-10-29 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.