AMP II
AMP II Plate and Center Screw, 2-Hole, 06
3manufacturers in China registered for this device type
25catalogue 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) | K242364 |
| Record published | 2026-02-18 |
| Record revised | 2025-11-20 (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, expiry date, manufacturing date |
| Sizes | Length 17 to 33 mm; width 11 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 616-1-06-S | Length 18 mm | In distribution |
| 616-2-06 | In distribution | |
| 616-1-10 | In distribution | |
| 614-102 | In distribution | |
| 616-2-08-S | Length 29 mm | In distribution |
| 616-2-10-S | Width 11 mm | In distribution |
| 616-2-08 | In distribution | |
| 616-1-12-S | Width 11 mm | In distribution |
| 614-103 | In distribution | |
| 616-2-04-S | Length 25 mm | In distribution |
| 616-1-08 | In distribution | |
| 614-110 | In distribution | |
| 616-2-04 | In distribution | |
| 616-2-10 | In distribution | |
| 616-1-04 | In distribution | |
| 614-113 | In distribution | |
| 616-1-04-S | Length 17 mm | In distribution |
| 616-1-06 | In distribution | |
| 616-2-12-S | Length 33 mm | In distribution |
| 614-100 | In distribution | |
| 614-101 | In distribution | |
| 616-1-10-S | Length 20 mm | In distribution |
| 614-111 | In distribution | |
| 616-2-06-S | Length 27 mm | In distribution |
| 616-1-08-S | Length 19 mm | In distribution |
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.