Valiant™ Anterior Lumbar Plate System
53 catalogue numbers from 14-530207, listed by Biomet Spine, United States, under Appliance, Fixation, Spinal Intervertebral Body. 14 manufacturers in China are registered for this product code.
14manufacturers in China registered for this device type
53catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Biomet Spine, United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Record published | 2020-06-25 |
| Record revised | 2025-07-02 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 14-530207 | VALIANT 6.25MMX34MM SCREW PENTALOBE, VALIANT | In distribution |
| 14-530195 | VALIANT 5.5MMX30MM SCREW PENTALOBE, VALIANT | In distribution |
| 14-530163 | VALIANT 39MM LUMBOSACRAL | In distribution |
| 14-530194 | VALIANT 5.5MMX28MM SCREW | In distribution |
| 14-530200 | VALIANT 6.25MMX20MM SCREW PENTALOBE, VALIANT | In distribution |
| 14-530202 | VALIANT 6.25MMX24MM SCREW PENTALOBE, VALIANT | In distribution |
| 14-530166 | VALIANT 45MM LUMBOSACRAL PLATE, VALIANT | In distribution |
| 14-530206 | VALIANT 6.25MMX32MM SCREW PENTALOBE, VALIANT | In distribution |
| 14-530196 | VALIANT 5.5MMX32MM SCREW PENTALOBE, VALIANT | In distribution |
| 14-530205 | VALIANT 6.25MMX30MM SCREW PENTALOBE, VALIANT | In distribution |
| 14-530161 | VALIANT 35MM LUMBOSACRAL PLATE, VALIANT | In distribution |
| 14-530200 | VALIANT 6.25MMX20MM SCREW | In distribution |
| 14-530201 | VALIANT 6.25MMX22MM SCREW PENTALOBE, VALIANT | In distribution |
| 14-530192 | VALIANT 5.5MMX24MM SCREW PENTALOBE, VALIANT | In distribution |
| 14-530190 | VALIANT 5.5MMX20MM SCREW | In distribution |
| 14-530194 | VALIANT 5.5MMX28MM SCREW PENTALOBE, VALIANT | In distribution |
| 14-530152 | VALIANT 37MM LUMBAR PLATE | In distribution |
| 14-530206 | VALIANT 6.25MMX32MM SCREW | In distribution |
| 14-530190 | VALIANT 5.5MMX20MM SCREW PENTALOBE, VALIANT | In distribution |
| 14-530165 | VALIANT 43MM LUMBOSACRAL PLATE, VALIANT | In distribution |
| 14-530165 | VALIANT 43MM LUMBOSACRAL | In distribution |
| 14-530193 | VALIANT 5.5MMX26MM SCREW | In distribution |
| 14-530204 | VALIANT 6.25MMX28MM SCREW | In distribution |
| 14-530163 | VALIANT 39MM LUMBOSACRAL PLATE, VALIANT | In distribution |
| 14-530166 | VALIANT 45MM LUMBOSACRAL | In distribution |
| 14-530195 | VALIANT 5.5MMX30MM SCREW | In distribution |
| 14-530203 | VALIANT 6.25MMX26MM SCREW | In distribution |
| 14-530162 | VALIANT 37MM LUMBOSACRAL | In distribution |
| 14-530154 | VALIANT 41MM LUMBAR PLATE | In distribution |
| 14-530150 | VALIANT 33MM LUMBAR PLATE | In distribution |
| 14-530197 | VALIANT 5.5MMX34MM SCREW | In distribution |
| 14-530191 | VALIANT 5.5MMX22MM SCREW | In distribution |
| 14-530203 | VALIANT 6.25MMX26MM SCREW PENTALOBE, VALIANT | In distribution |
| 14-530162 | VALIANT 37MM LUMBOSACRAL PLATE, VALIANT | In distribution |
| 14-530202 | VALIANT 6.25MMX24MM SCREW | In distribution |
| 14-530153 | VALIANT 39MM LUMBAR PLATE | In distribution |
| 14-530160 | VALIANT 33MM LUMBOSACRAL | In distribution |
| 14-530197 | VALIANT 5.5MMX34MM SCREW PENTALOBE, VALIANT | In distribution |
| 14-530196 | VALIANT 5.5MMX32MM SCREW | In distribution |
| 14-530164 | VALIANT 41MM LUMBOSACRAL PLATE, VALIANT | In distribution |
| 14-530193 | VALIANT 5.5MMX26MM SCREW PENTALOBE, VALIANT | In distribution |
| 14-530161 | VALIANT 35MM LUMBOSACRAL | In distribution |
| 14-530207 | VALIANT 6.25MMX34MM SCREW | In distribution |
| 14-530204 | VALIANT 6.25MMX28MM SCREW PENTALOBE, VALIANT | In distribution |
| 14-530164 | VALIANT 41MM LUMBOSACRAL | In distribution |
| 14-530201 | VALIANT 6.25MMX22MM SCREW | In distribution |
| 14-530155 | VALIANT 43MM LUMBAR PLATE | In distribution |
| 14-530151 | VALIANT 35MM LUMBAR PLATE | In distribution |
| 14-530205 | VALIANT 6.25MMX30MM SCREW | In distribution |
| 14-530156 | VALIANT 45MM LUMBAR PLATE | In distribution |
| 14-530192 | VALIANT 5.5MMX24MM SCREW | In distribution |
| 14-530191 | VALIANT 5.5MMX22MM SCREW PENTALOBE, VALIANT | In distribution |
| 14-530160 | VALIANT 33MM LUMBOSACRAL PLATE, VALIANT | 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 |
|---|---|
| K103393 | 2011-02-02 |
| K080646 | 2008-05-02 |
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.