E3D®-C Interbody System
HAnano Integrated Cervical 14'12mm 12Deg 11mm
7manufacturers in China registered for this device type
247catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Shanghai (2), Shandong (2), Zhejiang (2). 3 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 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
| Shanghai Sanyou Medical Co., Ltd. | Shanghai | Shanghai | Manufacturer | 6 |
Record
| Listed by | Evolution Spine, LLC, United States |
|---|---|
| FDA product code | ODP |
| Device type | Intervertebral Fusion Device With Bone Graft, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K241846 |
| Record published | 2024-10-04 |
| Record revised | 2025-07-14 (version 2) |
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 |
| Sizes | Height 5 to 12 mm; angle 7 to 15 °; depth 12 to 16 mm; width 14 to 18 mm; length 10 to 26 mm; outer diameter 3.5 to 4 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 130H-3520 | Length 20 mm | In distribution |
| 130G-XL1506 | In distribution | |
| 131H-S1509 | Height 9 mm | In distribution |
| 130H-M0710 | Depth 14 mm | In distribution |
| 130G-M1206 | Width 16 mm | In distribution |
| 131H-M1206 | Depth 14 mm | In distribution |
| 131G-L1209 | Height 9 mm | In distribution |
| 130G-XL1211 | In distribution | |
| 131H-M1207 | Depth 14 mm | In distribution |
| 131G-M0708 | Depth 14 mm | In distribution |
| 131H-S1207 | Depth 12 mm | In distribution |
| 131H-S1510 | Width 14 mm | In distribution |
| 131G-2XL0708 | In distribution | |
| 131G-XL1511 | In distribution | |
| 130G-M1507 | Depth 14 mm | In distribution |
| 130G-3XL1210 | In distribution | |
| 132-16 | Length 16 mm | In distribution |
| 130H-L1508 | Depth 16 mm | In distribution |
| 130G-XL1512 | In distribution | |
| 130G-L1208 | Depth 16 mm | In distribution |
| 130G-3XL0710 | In distribution | |
| 130G-3XL1206 | In distribution | |
| 131H-L1207 | Depth 16 mm | In distribution |
| 130G-L1209 | Width 18 mm | In distribution |
| 131H-L1512 | Width 18 mm | In distribution |
| 130H-S1211 | Depth 12 mm | In distribution |
| 130G-M1207 | Depth 14 mm | In distribution |
| 131G-L1207 | Height 7 mm | In distribution |
| 131H-L0706 | Height 6 mm | In distribution |
| 130G-2XL0710 | In distribution | |
| 131G-2XL0705 | In distribution | |
| 130G-3XL0709 | In distribution | |
| 131G-M1507 | Width 16 mm | In distribution |
| 130G-3XL0705 | In distribution | |
| 131G-3XL0707 | In distribution | |
| 130G-M1506 | Height 6 mm | In distribution |
| 130H-L1506 | Depth 16 mm | In distribution |
| 130G-2XL1512 | In distribution | |
| 130H-S0705 | Depth 12 mm | In distribution |
| 131G-L1508 | Angle 15 ° | In distribution |
| 132H-16-2 | Length 16 mm | In distribution |
| 131H-S1209 | Depth 12 mm | In distribution |
| 130H-3524-2 | Outer Diameter 3.5 mm | In distribution |
| 130G-2XL1511 | In distribution | |
| 130-4022 | Length 22 mm | In distribution |
| 131G-XL1507 | In distribution | |
| 131G-S0710 | Depth 12 mm | In distribution |
| 131G-S1207 | Height 7 mm | In distribution |
| 131G-M1506 | Height 6 mm | In distribution |
| 130G-2XL1509 | In distribution | |
| 131H-S0706 | Depth 12 mm | In distribution |
| 131H-S0707 | Angle 7 ° | In distribution |
| 131G-3XL1209 | In distribution | |
| 131G-L1506 | Width 18 mm | In distribution |
| 131G-2XL0710 | In distribution | |
| 130-4014 | Outer Diameter 4 mm | In distribution |
| 131G-3XL1210 | In distribution | |
| 130G-S1509 | Width 14 mm | In distribution |
| 130H-S0710 | Depth 12 mm | In distribution |
| 131H-L0712 | Width 18 mm | In distribution |
| 130G-3XL1510 | In distribution | |
| 130G-M1211 | Height 11 mm | In distribution |
| 131H-L1509 | Depth 16 mm | In distribution |
| 131H-S1211 | Height 11 mm | In distribution |
| 130G-XL1511 | In distribution | |
| 131G-XL1508 | In distribution | |
| 131G-L1208 | Height 8 mm | In distribution |
| 131G-3XL1207 | In distribution | |
| 131H-L1510 | Height 10 mm | In distribution |
| 130-3512 | Outer Diameter 3.5 mm | In distribution |
| 131G-S1509 | Width 14 mm | In distribution |
| 130G-S0712 | Width 14 mm | In distribution |
| 130H-S1509 | Height 9 mm | In distribution |
| 130G-L0712 | Depth 16 mm | In distribution |
| 131H-S1507 | Height 7 mm | In distribution |
| 131G-L1206 | Angle 12 ° | In distribution |
| 130G-M1209 | Height 9 mm | In distribution |
| 130H-3518-2 | Length 18 mm | In distribution |
| 130G-3XL1511 | In distribution | |
| 130G-3XL1212 | In distribution | |
| 130H-S0708 | Depth 12 mm | In distribution |
| 131H-S1210 | Angle 12 ° | In distribution |
| 131G-XL1211 | In distribution | |
| 130H-L1507 | Depth 16 mm | In distribution |
| 131H-L1511 | Width 18 mm | In distribution |
| 130H-S0707 | Height 7 mm | In distribution |
| 132H-14-2 | Length 14 mm | In distribution |
| 131H-M1509 | Depth 14 mm | In distribution |
| 130-3514 | Outer Diameter 3.5 mm | In distribution |
| 130H-M1506 | Depth 14 mm | In distribution |
| 130H-L0712 | Width 18 mm | In distribution |
| 131H-L1508 | Height 8 mm | In distribution |
| 130G-S0705 | Angle 7 ° | In distribution |
| 130G-M1509 | Depth 14 mm | In distribution |
| 130H-M1208 | Width 16 mm | In distribution |
| 130G-L1509 | Height 9 mm | In distribution |
| 130H-M1507 | Height 7 mm | In distribution |
| 131G-S0709 | Depth 12 mm | In distribution |
| 130G-L1511 | Depth 16 mm | In distribution |
| 130G-L0710 | Width 18 mm | In distribution |
| 131G-XL0707 | In distribution | |
| 131G-L1212 | Depth 16 mm | In distribution |
| 130G-XL0708 | In distribution | |
| 131G-2XL1508 | In distribution | |
| 130G-M0706 | Depth 14 mm | In distribution |
| 130G-3XL0706 | In distribution | |
| 131G-S0707 | Width 14 mm | In distribution |
| 131G-2XL1207 | In distribution | |
| 130G-L1211 | Depth 16 mm | In distribution |
| 130H-L1211 | Width 18 mm | In distribution |
| 130G-2XL1507 | In distribution | |
| 131H-S0711 | Angle 7 ° | In distribution |
| 131G-S1512 | Depth 12 mm | In distribution |
| 130H-M1510 | Height 10 mm | In distribution |
| 130G-2XL1206 | In distribution | |
| 130-4026 | Outer Diameter 4 mm | In distribution |
| 130H-3512 | Outer Diameter 3.5 mm | In distribution |
| 131G-M1206 | Width 16 mm | In distribution |
| 130G-M1512 | Angle 15 ° | In distribution |
| 130H-M1212 | Depth 14 mm | In distribution |
| 130H-M0708 | Depth 14 mm | In distribution |
| 131G-M0706 | Depth 14 mm | In distribution |
| 131G-2XL0707 | In distribution | |
| 131H-L0708 | Angle 7 ° | In distribution |
| 130H-4018 | Length 18 mm | In distribution |
| 130G-2XL1208 | In distribution | |
| 130-4010 | Length 10 mm | In distribution |
| 131G-3XL1507 | In distribution | |
| 130G-M1508 | Depth 14 mm | In distribution |
| 130H-S1207 | Height 7 mm | In distribution |
| 130H-4012 | Outer Diameter 4 mm | In distribution |
| 130H-S1506 | Height 6 mm | In distribution |
| 130H-S0706 | Height 6 mm | In distribution |
| 131H-M0707 | Angle 7 ° | In distribution |
| 130H-4010-2 | Length 10 mm | In distribution |
| 131G-3XL1206 | In distribution | |
| 130H-3526 | Length 26 mm | In distribution |
| 131H-M1512 | Depth 14 mm | In distribution |
| 131G-L1509 | Height 9 mm | In distribution |
| 131H-M1510 | Depth 14 mm | In distribution |
| 130G-XL1510 | In distribution | |
| 130H-M0707 | Width 16 mm | In distribution |
| 130-3520 | Length 20 mm | In distribution |
| 130G-2XL1210 | In distribution | |
| 132H-18 | Length 18 mm | In distribution |
| 130H-S1210 | Angle 12 ° | In distribution |
| 130G-2XL1510 | In distribution | |
| 131G-XL0709 | In distribution | |
| 131G-2XL1512 | In distribution | |
| 131H-M0712 | Width 16 mm | In distribution |
| 130G-L1207 | Depth 16 mm | In distribution |
| 130-4012 | Outer Diameter 4 mm | In distribution |
| 130G-2XL1212 | In distribution | |
| 130H-S1510 | Angle 15 ° | In distribution |
| 130G-L0706 | Angle 7 ° | In distribution |
| 130H-M1512 | Height 12 mm | In distribution |
| 131G-L1210 | Width 18 mm | In distribution |
| 131G-XL1210 | In distribution | |
| 131H-S0712 | Height 12 mm | In distribution |
| 131G-XL1208 | In distribution | |
| 131G-L1507 | Height 7 mm | In distribution |
| 131G-2XL1509 | In distribution | |
| 130G-L1507 | Depth 16 mm | In distribution |
| 131H-M0708 | Width 16 mm | In distribution |
| 130G-S1510 | Height 10 mm | In distribution |
| 131G-M1511 | Height 11 mm | In distribution |
| 131H-L0705 | Height 5 mm | In distribution |
| 131G-L1512 | Angle 15 ° | In distribution |
| 131H-S0709 | Width 14 mm | In distribution |
| 132H-18-2 | Length 18 mm | In distribution |
| 130G-S0710 | Width 14 mm | In distribution |
| 131G-S0706 | Angle 7 ° | In distribution |
| 131H-M1507 | Angle 15 ° | In distribution |
| 130-3526 | Outer Diameter 3.5 mm | In distribution |
| 130-3510 | Length 10 mm | In distribution |
| 131G-3XL0712 | In distribution | |
| 131G-XL0705 | In distribution | |
| 130H-L1206 | Width 18 mm | In distribution |
| 131H-M1508 | Height 8 mm | In distribution |
| 130-3524 | Length 24 mm | In distribution |
| 131G-L0710 | Depth 16 mm | In distribution |
| 131G-M0712 | Angle 7 ° | In distribution |
| 131G-3XL1212 | In distribution | |
| 130H-L1512 | Height 12 mm | In distribution |
| 131G-XL1209 | In distribution | |
| 130H-4026 | Length 26 mm | In distribution |
| 131G-3XL0711 | In distribution | |
| 131H-M0709 | Depth 14 mm | In distribution |
| 131H-S1212 | Depth 12 mm | In distribution |
| 131G-M1208 | Height 8 mm | In distribution |
| 130G-3XL1211 | In distribution | |
| 131G-XL0710 | In distribution | |
| 131G-L1211 | Width 18 mm | In distribution |
| 131G-2XL0712 | In distribution | |
| 131H-M0711 | Depth 14 mm | In distribution |
| 131G-3XL0708 | In distribution | |
| 130H-M1511 | Width 16 mm | In distribution |
| 131G-3XL1509 | In distribution | |
| 130G-XL1208 | In distribution | |
| 131H-M1211 | Angle 12 ° | In distribution |
| 131G-S1212 | Height 12 mm | In distribution |
| 130H-3522-2 | Length 22 mm | In distribution |
| 131H-L1208 | Angle 12 ° | In distribution |
| 131G-2XL1211 | In distribution | |
| 130G-S1211 | Width 14 mm | In distribution |
| 131H-S0710 | Depth 12 mm | In distribution |
| 130G-XL0710 | In distribution | |
| 130G-M1511 | Height 11 mm | In distribution |
| 131G-2XL0706 | In distribution | |
| 131G-M1209 | Depth 14 mm | In distribution |
| 130H-4024-2 | Outer Diameter 4 mm | In distribution |
| 130G-XL1507 | In distribution | |
| 131G-S0712 | Depth 12 mm | In distribution |
| 130H-L1509 | Width 18 mm | In distribution |
| 130H-4016-2 | Length 16 mm | In distribution |
| 131G-2XL1208 | In distribution | |
| 130H-4014 | Length 14 mm | In distribution |
| 130G-3XL0712 | In distribution | |
| 131G-XL1212 | In distribution | |
| 130H-L1210 | Depth 16 mm | In distribution |
| 130G-XL0707 | In distribution | |
| 131G-L0708 | Depth 16 mm | In distribution |
| 130G-S1206 | Depth 12 mm | In distribution |
| 131G-M1207 | Height 7 mm | In distribution |
| 131H-L0709 | Depth 16 mm | In distribution |
| 131G-2XL1507 | In distribution | |
| 131G-S1206 | Depth 12 mm | In distribution |
| 131G-2XL1506 | In distribution | |
| 131G-2XL0711 | In distribution | |
| 130G-3XL1506 | In distribution | |
| 130H-L0708 | Height 8 mm | In distribution |
| 131G-L1510 | Depth 16 mm | In distribution |
| 130-4018 | Outer Diameter 4 mm | In distribution |
| 130G-L1212 | Width 18 mm | In distribution |
| 131H-L0711 | Angle 7 ° | In distribution |
| 130H-S1212 | Angle 12 ° | In distribution |
| 131G-3XL0706 | In distribution | |
| 131G-3XL0705 | In distribution | |
| 130G-M0705 | Height 5 mm | In distribution |
| 131G-M0710 | Angle 7 ° | In distribution |
| 130G-L0709 | Depth 16 mm | In distribution |
| 130G-3XL1507 | In distribution | |
| 130G-XL0709 | In distribution | |
| 130G-XL1509 | In distribution | |
| 131G-2XL1510 | In distribution | |
| 130G-L1210 | Height 10 mm | In distribution |
| 130G-XL1508 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Latitude-C AM™ Cervical Interbody Fusion System | Degen Medical | 1,529 |
| IdentiTi | Alphatec Spine, Inc. | 1,390 |
| Zavation | Zavation | 1,357 |
| IVA Cage Ti | Diomedical Co., Ltd. | 1,202 |
| Latitude-C Cervical Interbody Spacer System | Degen Medical | 1,185 |
| Peridot Anterior Cervical Intervertebral Body Fusion System | Gbs Commonwealth Co., Ltd. | 1,056 |
| Aleutian® Interbody Systems | VB Spine LLC | 1,017 |
| Valeo Spacer System | Sintx Technologies Inc. | 918 |
| Cascadia™ Interbody System | VB Spine LLC | 823 |
| CoRoent | Nuvasive, Inc. | 815 |
| Tyber Medical | Tyber Medical | 740 |
| Matisse Anterior Cervical Interbody Fusion Cage System | CTL Medical Corporation | 577 |
Showing 12 of 938. All products under Intervertebral Fusion Device With Bone Graft, Cervical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K160324 | 2016-05-05 |
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.