Unity
Screw, 1/4-28 Locking Anterior Lumbar System NEW P/N 90-1481
14manufacturers in China registered for this device type
33catalogue numbers in this listing
1510(k) clearance
1recall
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (2). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 14. All 14 manufacturers in China registered for Appliance, Fixation, Spinal Intervertebral Body
Record
| Listed by | Orthofix US LLC, United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K061229 |
| Record published | 2017-08-01 |
| Record revised | 2026-02-20 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Sizes | Length 17 to 35 mm; outer diameter 6 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 43-3019 | Length 28 mm | In distribution |
| 43-3025 | Length 25 mm | In distribution |
| 43-6525 | Outer Diameter 6 mm | In distribution |
| 43-1028 | Length 28 mm | In distribution |
| 43-3028 | Length 28 mm | In distribution |
| 43-4031 | Length 31 mm | In distribution |
| 450195-0002 | In distribution | |
| 43-6535 | Outer Diameter 6 mm | In distribution |
| 43-3021 | Length 21 mm | In distribution |
| 43-4021 | Length 21 mm | In distribution |
| 43-2023 | Length 23 mm | In distribution |
| 43-1021 | Length 21 mm | In distribution |
| 43-2021 | Length 21 mm | In distribution |
| 450196-0002 | In distribution | |
| 43-3023 | Length 23 mm | In distribution |
| 43-1019 | Length 19 mm | In distribution |
| 43-7535 | Outer Diameter 6 mm | In distribution |
| 43-4019 | Length 19 mm | In distribution |
| 43-2025 | Length 25 mm | In distribution |
| 43-6530 | Outer Diameter 6 mm | In distribution |
| 43-6001 | In distribution | |
| 43-2017 | Length 17 mm | In distribution |
| 43-2028 | Length 28 mm | In distribution |
| 43-1025 | Length 25 mm | In distribution |
| 43-7530 | Outer Diameter 6 mm | In distribution |
| 43-4025 | Length 25 mm | In distribution |
| 43-7525 | Outer Diameter 6 mm | In distribution |
| 43-3031 | Length 31 mm | In distribution |
| 43-4028 | Length 28 mm | In distribution |
| 43-4023 | Length 23 mm | In distribution |
| 43-1023 | Length 23 mm | In distribution |
| 43-1017 | Length 23 mm | In distribution |
| 43-2019 | Length 19 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ReLine | Nuvasive, Inc. | 2,998 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,568 |
| Creo | Globus Medical, Inc. | 1,765 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 1,755 |
| Ozark Cervical Plate System | VB Spine LLC | 1,460 |
| Sirion | Astura Medical | 1,246 |
| Apex Spine System | Spinecraft LLC | 1,187 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 986 |
| Astra Spine System | Spinecraft LLC | 970 |
| Zavation | Zavation | 966 |
| ACP | Nuvasive, Inc. | 918 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 877 |
Showing 12 of 855. All products under Appliance, Fixation, Spinal Intervertebral Body
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K211712 | 2022-02-11 |
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 | Closed |
|---|---|---|---|---|---|
| 2013-10-29 | Class II | Component design/selection | There is a possibility that the locking mechanism of the Azure Anterior Cervical Plate may fracture during or after implantation. | 4,172 units | 2014-12-09 |
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.