AMP
LIF AMP, ONE Screw Plate, 16 AND Center Screw, 17.5MM
3manufacturers in China registered for this device type
279catalogue numbers in this listing
5510(k) clearances naming this product code
1recall
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 | Alphatec Spine, Inc., 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, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K202587 |
| Record published | 2021-01-13 |
| Record revised | 2024-09-11 (version 5) |
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 |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Length 4 to 65 mm; outer diameter 5.5 to 6.5 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 116-1-3-12-S | In distribution | |
| 116-1-06 | Length 6 mm | In distribution |
| 116-1-4-16-S | In distribution | |
| 116-4-5525 | Outer Diameter 5.5 mm | In distribution |
| 116-1-4-04-S | In distribution | |
| 116-1-3-09-S | In distribution | |
| 116-1-10 | Length 10 mm | In distribution |
| 116-01-20 | Length 20 mm | In distribution |
| 116-4-6040-2-S | Length 40 mm | In distribution |
| 116-2-5-04-S | In distribution | |
| 116-4-5530 | Length 30 mm | In distribution |
| 116-4-5545 | Length 45 mm | In distribution |
| 116-01-11 | Length 11 mm | In distribution |
| 116-1-1-09-S | In distribution | |
| 116-1-5-15-S | In distribution | |
| 116-4-6535-2-S | Length 35 mm | In distribution |
| 116-02-10 | Length 10 mm | In distribution |
| 116-2-07 | Length 7 mm | In distribution |
| 116-4-5555-2-S | Length 55 mm | In distribution |
| 116-1-3-14-S | In distribution | |
| 116-1-4-06-S | In distribution | |
| 116-3-01 | Length 10 mm | In distribution |
| 116-1-5-09-S | In distribution | |
| 116-2-2-09-S | In distribution | |
| 116-1-2-06-S | In distribution | |
| 116-4-5565-2-S | Length 65 mm | In distribution |
| 116-1-2-08-S | In distribution | |
| 116-1-04 | Length 4 mm | In distribution |
| 116-1-4-08-S | In distribution | |
| 116-2-5-09-S | In distribution | |
| 116-04-5535 | Outer Diameter 5.5 mm | In distribution |
| 116-1-5-10-S | In distribution | |
| 116-02-11 | Length 11 mm | In distribution |
| 116-3-05 | Length 20 mm | In distribution |
| 116-04-5550 | Outer Diameter 5.5 mm | In distribution |
| 116-1-1-08-S | In distribution | |
| 116-2-2-06-S | In distribution | |
| 116-02-14 | Length 14 mm | In distribution |
| 116-4-5530-2-S | Outer Diameter 5.5 mm | In distribution |
| 116-04-5565 | Length 65 mm | In distribution |
| 116-2-2-08-S | In distribution | |
| 116-4-5565 | Length 65 mm | In distribution |
| 116-1-4-14-S | In distribution | |
| 116-2-4-15-S | In distribution | |
| 116-2-1-08-S | In distribution | |
| 116-1-13 | Length 13 mm | In distribution |
| 116-4-6035 | Outer Diameter 6 mm | In distribution |
| 116-2-06 | Length 6 mm | In distribution |
| 116-2-2-12-S | In distribution | |
| 116-04-6055 | Outer Diameter 6 mm | In distribution |
| 116-04-6045 | Outer Diameter 6 mm | In distribution |
| 116-2-2-16-S | In distribution | |
| 116-01-13 | Length 13 mm | In distribution |
| 116-01-12 | Length 12 mm | In distribution |
| 116-4-5535 | Outer Diameter 5.5 mm | In distribution |
| 116-4-6025 | Outer Diameter 6 mm | In distribution |
| 116-2-3-05-S | In distribution | |
| 116-04-5540 | Outer Diameter 5.5 mm | In distribution |
| 116-2-5-11-S | In distribution | |
| 116-4-6035-2-S | Length 35 mm | In distribution |
| 116-1-3-13-S | In distribution | |
| 116-01-22 | Length 22 mm | In distribution |
| 116-1-1-13-S | In distribution | |
| 116-1-1-05-S | In distribution | |
| 116-02-23 | Length 23 mm | In distribution |
| 116-04-6545 | Outer Diameter 6.5 mm | In distribution |
| 116-4-5535-2-S | Length 35 mm | In distribution |
| 116-2-5-07-S | In distribution | |
| 116-01-18 | Length 18 mm | In distribution |
| 116-1-5-16-S | In distribution | |
| 116-02-12 | Length 12 mm | In distribution |
| 116-4-6545-2-S | Length 45 mm | In distribution |
| 116-1-1-11-S | In distribution | |
| 116-2-10 | Length 10 mm | In distribution |
| 116-1-2-14-S | In distribution | |
| 116-2-1-15-S | In distribution | |
| 116-2-3-08-S | In distribution | |
| 116-04-6550 | Outer Diameter 6.5 mm | In distribution |
| 116-1-12 | Length 12 mm | In distribution |
| 116-2-05 | Length 5 mm | In distribution |
| 116-1-16 | Length 16 mm | In distribution |
| 116-2-4-10-S | In distribution | |
| 116-04-6040 | Outer Diameter 6 mm | In distribution |
| 116-04-5545 | Length 45 mm | In distribution |
| 116-1-3-15-S | In distribution | |
| 116-2-5-13-S | In distribution | |
| 116-1-3-11-S | In distribution | |
| 116-2-5-06-S | In distribution | |
| 116-1-07 | Length 7 mm | In distribution |
| 116-2-5-15-S | In distribution | |
| 116-2-1-06-S | In distribution | |
| 116-4-6565-2-S | Length 65 mm | In distribution |
| 116-2-16 | Length 16 mm | In distribution |
| 116-1-1-14-S | In distribution | |
| 116-1-1-10-S | In distribution | |
| 116-02-08 | Length 8 mm | In distribution |
| 116-1-5-08-S | In distribution | |
| 116-1-3-04-S | In distribution | |
| 116-1-3-10-S | In distribution | |
| 116-04-6560 | Outer Diameter 6.5 mm | In distribution |
| 116-02-13 | Length 13 mm | In distribution |
| 116-1-14 | Length 14 mm | In distribution |
| 116-1-4-05-S | In distribution | |
| 116-01-10 | Length 10 mm | In distribution |
| 116-2-4-04-S | In distribution | |
| 116-2-4-11-S | In distribution | |
| 116-03-04 | Length 17.5 mm | In distribution |
| 116-04-6065 | Outer Diameter 6 mm | In distribution |
| 116-1-3-05-S | In distribution | |
| 116-01-21 | Length 21 mm | In distribution |
| 116-1-1-04-S | In distribution | |
| 116-2-3-15-S | In distribution | |
| 116-2-1-12-S | In distribution | |
| 116-2-08 | Length 8 mm | In distribution |
| 116-2-3-11-S | In distribution | |
| 116-1-1-07-S | In distribution | |
| 116-2-1-07-S | In distribution | |
| 116-02-16 | Length 16 mm | In distribution |
| 116-4-6530 | Length 30 mm | In distribution |
| 116-2-1-16-S | In distribution | |
| 116-4-6030 | Outer Diameter 6 mm | In distribution |
| 116-2-3-10-S | In distribution | |
| 116-04-5555 | Length 55 mm | In distribution |
| 116-4-6560 | Length 60 mm | In distribution |
| 116-4-6030-2-S | Length 30 mm | In distribution |
| 116-2-5-14-S | In distribution | |
| 116-1-4-12-S | In distribution | |
| 116-01-16 | Length 16 mm | In distribution |
| 116-1-2-12-S | In distribution | |
| 116-1-5-04-S | In distribution | |
| 116-2-4-14-S | In distribution | |
| 116-2-1-05-S | In distribution | |
| 116-2-5-08-S | In distribution | |
| 116-01-15 | Length 15 mm | In distribution |
| 116-3-04 | Length 17.5 mm | In distribution |
| 116-2-3-13-S | In distribution | |
| 116-02-17 | Length 17 mm | In distribution |
| 116-1-5-07-S | In distribution | |
| 116-2-15 | Length 15 mm | In distribution |
| 116-2-1-13-S | In distribution | |
| 116-1-05 | Length 5 mm | In distribution |
| 116-04-6565 | Outer Diameter 6.5 mm | In distribution |
| 116-2-3-07-S | In distribution | |
| 116-1-4-09-S | In distribution | |
| 116-04-5525 | Outer Diameter 5.5 mm | In distribution |
| 116-4-6535 | Length 35 mm | In distribution |
| 116-1-5-12-S | In distribution | |
| 116-1-1-16-S | In distribution | |
| 116-1-4-10-S | In distribution | |
| 116-04-5560 | Outer Diameter 5.5 mm | In distribution |
| 116-1-11 | Length 11 mm | In distribution |
| 116-2-3-06-S | In distribution | |
| 116-2-3-16-S | In distribution | |
| 116-03-03 | Length 15 mm | In distribution |
| 116-2-4-13-S | In distribution | |
| 116-2-5-05-S | In distribution | |
| 116-4-5560 | Length 60 mm | In distribution |
| 116-4-6040 | Length 40 mm | In distribution |
| 116-1-5-13-S | In distribution | |
| 116-4-6540 | Outer Diameter 6.5 mm | In distribution |
| 116-4-6525-2-S | Length 25 mm | In distribution |
| 116-2-2-04-S | In distribution | |
| 116-2-2-14-S | In distribution | |
| 116-01-09 | Length 9 mm | In distribution |
| 116-2-1-14-S | In distribution | |
| 116-04-6060 | Length 60 mm | In distribution |
| 116-04-6035 | Outer Diameter 6 mm | In distribution |
| 116-04-6030 | Outer Diameter 6 mm | In distribution |
| 116-2-4-06-S | In distribution | |
| 116-02-18 | Length 18 mm | In distribution |
| 116-4-6055-2-S | Outer Diameter 6 mm | In distribution |
| 116-03-05 | Length 20 mm | In distribution |
| 116-2-5-10-S | In distribution | |
| 116-4-5560-2-S | Outer Diameter 5.5 mm | In distribution |
| 116-2-4-07-S | In distribution | |
| 116-1-2-11-S | In distribution | |
| 116-02-20 | Length 20 mm | In distribution |
| 116-4-6550-2-S | Length 50 mm | In distribution |
| 116-4-6055 | Outer Diameter 6 mm | In distribution |
| 116-1-2-05-S | In distribution | |
| 116-1-15 | Length 15 mm | In distribution |
| 116-1-4-11-S | In distribution | |
| 116-4-6565 | Length 65 mm | In distribution |
| 116-01-19 | Length 19 mm | In distribution |
| 116-4-5555 | Length 55 mm | In distribution |
| 116-4-5550 | Length 50 mm | In distribution |
| 116-4-6065-2-S | Outer Diameter 6 mm | In distribution |
| 116-04-6540 | Outer Diameter 6.5 mm | In distribution |
| 116-2-3-14-S | In distribution | |
| 116-02-22 | Length 22 mm | In distribution |
| 116-4-6065 | Length 65 mm | In distribution |
| 116-1-1-15-S | In distribution | |
| 116-2-3-04-S | In distribution | |
| 116-01-14 | Length 14 mm | In distribution |
| 116-2-12 | Length 12 mm | In distribution |
| 116-02-09 | Length 9 mm | In distribution |
| 116-4-6525 | Outer Diameter 6.5 mm | In distribution |
| 116-1-08 | Length 8 mm | In distribution |
| 116-4-5540 | Length 40 mm | In distribution |
| 116-4-6045-2-S | Outer Diameter 6 mm | In distribution |
| 116-1-2-15-S | In distribution | |
| 116-2-4-09-S | In distribution | |
| 116-1-5-14-S | In distribution | |
| 116-02-15 | Length 15 mm | In distribution |
| 116-1-2-16-S | In distribution | |
| 116-2-3-09-S | In distribution | |
| 116-2-2-05-S | In distribution | |
| 116-1-2-09-S | In distribution | |
| 116-04-6530 | Length 30 mm | In distribution |
| 116-2-4-16-S | In distribution | |
| 116-2-3-12-S | In distribution | |
| 116-4-6540-2-S | Length 40 mm | In distribution |
| 116-1-4-15-S | In distribution | |
| 116-4-6025-2-S | Outer Diameter 6 mm | In distribution |
| 116-4-6555 | Outer Diameter 6.5 mm | In distribution |
| 116-4-6545 | Outer Diameter 6.5 mm | In distribution |
| 116-4-6060-2-S | Outer Diameter 6 mm | In distribution |
| 116-4-5545-2-S | Outer Diameter 5.5 mm | In distribution |
| 116-04-5530 | Length 30 mm | In distribution |
| 116-1-1-06-S | In distribution | |
| 116-3-03 | Length 15 mm | In distribution |
| 116-1-3-16-S | In distribution | |
| 116-1-5-05-S | In distribution | |
| 116-4-6530-2-S | Outer Diameter 6.5 mm | In distribution |
| 116-4-5540-2-S | Length 40 mm | In distribution |
| 116-1-3-08-S | In distribution | |
| 116-2-2-11-S | In distribution | |
| 116-1-5-06-S | In distribution | |
| 116-01-23 | Length 23 mm | In distribution |
| 116-4-6555-2-S | Outer Diameter 6.5 mm | In distribution |
| 116-2-13 | Length 13 mm | In distribution |
| 116-4-6560-2-S | Length 60 mm | In distribution |
| 116-03-01 | Length 10 mm | In distribution |
| 116-2-1-09-S | In distribution | |
| 116-4-6550 | Length 50 mm | In distribution |
| 116-01-08 | Length 8 mm | In distribution |
| 116-4-6050 | Outer Diameter 6 mm | In distribution |
| 116-04-6535 | Length 35 mm | In distribution |
| 116-01-17 | Length 17 mm | In distribution |
| 116-1-09 | Length 9 mm | In distribution |
| 116-2-5-16-S | In distribution | |
| 116-2-11 | Length 11 mm | In distribution |
| 116-3-02 | Length 12.5 mm | In distribution |
| 116-2-2-13-S | In distribution | |
| 116-1-2-04-S | In distribution | |
| 116-2-14 | Length 14 mm | In distribution |
| 116-2-2-10-S | In distribution | |
| 116-2-4-12-S | In distribution | |
| 116-1-2-13-S | In distribution | |
| 116-02-19 | Length 19 mm | In distribution |
Showing 250 of 279 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 |
| Solar™ Interbody Fusion System | Degen Medical | 899 |
| 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 |
Showing 12 of 241. All products under Intervertebral Fusion Device With Integrated Fixation, Lumbar
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251575 | 2025-09-03 |
| K232097 | 2023-09-25 |
| K203742 | 2021-04-09 |
| K123993 | 2013-03-05 |
| K102402 | 2011-03-30 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-01-26 | Class II | Device Design | Due to reports of intraoperative graft bolt implantation breakages. | 12,777 devices |
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.