Vectra
TI Vectra(TM) Plate 4 LEVEL/100MM
14manufacturers in China registered for this device type
41catalogue 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 | Synthes Gmbh, Switzerland |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K050451 |
| Record published | 2015-09-14 |
| Record revised | 2025-11-20 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 04.613.372 | In distribution | |
| 04.613.260 | In distribution | |
| 04.613.242 | In distribution | |
| 04.613.263 | In distribution | |
| 04.613.128 | In distribution | |
| 04.613.134 | In distribution | |
| 04.613.245 | In distribution | |
| 04.613.392 | In distribution | |
| 04.613.016 | In distribution | |
| 04.613.380 | In distribution | |
| 04.613.248 | In distribution | |
| 04.613.126 | In distribution | |
| 04.613.376 | In distribution | |
| 04.613.026 | In distribution | |
| 04.613.368 | In distribution | |
| 04.613.384 | In distribution | |
| 04.613.239 | In distribution | |
| 04.613.251 | In distribution | |
| 04.613.014 | In distribution | |
| 04.613.146 | In distribution | |
| 04.613.364 | In distribution | |
| 04.613.388 | In distribution | |
| 04.613.012 | In distribution | |
| 04.613.360 | In distribution | |
| 04.613.138 | In distribution | |
| 04.613.266 | In distribution | |
| 04.613.140 | In distribution | |
| 04.613.018 | In distribution | |
| 04.613.022 | In distribution | |
| 04.613.269 | In distribution | |
| 04.613.142 | In distribution | |
| 04.613.132 | In distribution | |
| 04.613.254 | In distribution | |
| 04.613.257 | In distribution | |
| 04.613.144 | In distribution | |
| 04.613.136 | In distribution | |
| 04.613.400 | In distribution | |
| 04.613.020 | In distribution | |
| 04.613.024 | In distribution | |
| 04.613.130 | In distribution | |
| 04.613.396 | 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 |
|---|---|
| K003061 | 2000-10-30 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Synthes Gmbh | 510(k) number | 2014-09-02 | Class II | Employee error | DePuy Synthes is initiating a voluntary medical device recall of certain lots of the TI Vectra Plates, which is a part of the DePuy Synthes Vectra Anterior Cervical Plate Family of Systems. The Vectra Systems are intended for anterior scre | 16 | 2015-09-02 |
| Synthes USA (HQ), Inc. | 510(k) number | 2012-08-06 | Class II | Component design/selection | Although the reported incidence is low, there is the potential for the drill stop to slip on the drill bit resulting in an adverse event. | 63 | 2015-08-31 |
| Synthes USA (HQ), Inc. | 510(k) number | 2012-08-06 | Class II | Component design/selection | Although the reported incidence is low, there is the potential for the drill stop to slip on the drill bit resulting in an adverse event. | 48 | 2015-08-31 |
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.