Appliance, Fixation, Spinal Intervertebral Body
4.0MM TI Cerv Self-Retain Crtx SCR/SLF-Tpng/Variable ANG 22M
14manufacturers in China registered for this device type
307catalogue 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) | K093668 |
| Record published | 2015-09-14 |
| Record revised | 2025-02-06 (version 7) |
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 |
|---|---|---|
| 04.613.565 | In distribution | |
| 04.613.864 | In distribution | |
| 499.226 | In distribution | |
| 04.614.622 | In distribution | |
| 04.613.762 | In distribution | |
| 498.320 | In distribution | |
| 299.900 | In distribution | |
| 09.633.190 | In distribution | |
| 04.613.818 | In distribution | |
| 04.613.716 | In distribution | |
| 04.636.070 | In distribution | |
| 04.610.618 | In distribution | |
| 298.154 | In distribution | |
| 04.610.616 | In distribution | |
| 04.610.518 | In distribution | |
| 298.103 | In distribution | |
| 498.413 | In distribution | |
| 04.613.515 | In distribution | |
| 489.142 | In distribution | |
| 04.613.570 | In distribution | |
| 498.877 | In distribution | |
| 498.863 | In distribution | |
| 04.613.513 | In distribution | |
| 298.285 | In distribution | |
| 04.651.450 | In distribution | |
| 450.137 | In distribution | |
| 04.610.218 | In distribution | |
| 04.613.663 | In distribution | |
| 450.139 | In distribution | |
| 04.613.870 | In distribution | |
| 04.613.869 | In distribution | |
| 241.55 | In distribution | |
| 04.636.075 | In distribution | |
| 406.040 | In distribution | |
| 04.613.719 | In distribution | |
| 496.784 | In distribution | |
| 450.145 | In distribution | |
| 04.613.517 | In distribution | |
| 450.148 | In distribution | |
| 04.613.562 | In distribution | |
| 450.144 | In distribution | |
| 04.602.001 | In distribution | |
| 04.610.212 | In distribution | |
| 04.622.317 | In distribution | |
| 496.750 | In distribution | |
| 498.294 | In distribution | |
| 498.860 | In distribution | |
| 241.59 | In distribution | |
| 04.613.619 | In distribution | |
| 497.798 | In distribution | |
| 04.610.514 | In distribution | |
| 04.613.520 | In distribution | |
| 04.613.767 | In distribution | |
| 499.106 | In distribution | |
| 450.127 | In distribution | |
| 406.012 | In distribution | |
| 04.201.020 | In distribution | |
| 04.651.550 | In distribution | |
| 498.393 | In distribution | |
| 09.631.125 | In distribution | |
| 04.636.035 | In distribution | |
| 04.601.010 | In distribution | |
| 04.201.026 | In distribution | |
| 298.239 | In distribution | |
| 241.51 | In distribution | |
| 498.416 | In distribution | |
| 04.613.868 | In distribution | |
| 04.201.024 | In distribution | |
| 04.202.034 | In distribution | |
| 499.273 | In distribution | |
| 489.147 | In distribution | |
| 298.282 | In distribution | |
| 04.610.520 | In distribution | |
| 406.024 | In distribution | |
| 04.201.036 | In distribution | |
| 487.046 | In distribution | |
| 241.53 | In distribution | |
| 04.613.866 | In distribution | |
| 499.272 | In distribution | |
| 09.636.080 | In distribution | |
| 498.288 | In distribution | |
| 241.57 | In distribution | |
| 04.610.116 | In distribution | |
| 02.622.317 | In distribution | |
| 489.168 | In distribution | |
| 04.610.220 | In distribution | |
| 04.613.815 | In distribution | |
| 04.613.665 | In distribution | |
| 04.610.516 | In distribution | |
| 04.613.664 | In distribution | |
| 487.056 | In distribution | |
| 09.636.125 | In distribution | |
| 488.814 | In distribution | |
| 04.201.022 | In distribution | |
| 04.613.563 | In distribution | |
| 04.651.290 | In distribution | |
| 04.613.662 | In distribution | |
| 498.773 | In distribution | |
| 498.236 | In distribution | |
| 04.613.867 | In distribution | |
| 04.202.030 | In distribution | |
| 498.418 | In distribution | |
| 498.352 | In distribution | |
| 04.610.214 | In distribution | |
| 241.50 | In distribution | |
| 04.613.668 | In distribution | |
| 498.695 | In distribution | |
| 04.610.512 | In distribution | |
| 04.613.617 | In distribution | |
| 04.633.395 | In distribution | |
| 499.263 | In distribution | |
| 499.112 | In distribution | |
| 499.284 | In distribution | |
| 498.693 | In distribution | |
| 498.423 | In distribution | |
| 450.141 | In distribution | |
| 04.613.518 | In distribution | |
| 04.202.036 | In distribution | |
| 09.633.100 | In distribution | |
| 04.613.516 | In distribution | |
| 04.614.674 | In distribution | |
| 498.184 | In distribution | |
| 04.613.720 | In distribution | |
| 04.613.670 | In distribution | |
| 498.884 | In distribution | |
| 298.279 | In distribution | |
| 489.165 | In distribution | |
| 04.600.014 | In distribution | |
| 09.636.045 | In distribution | |
| 499.104 | In distribution | |
| 04.202.022 | In distribution | |
| 406.045 | In distribution | |
| 04.202.020 | In distribution | |
| 04.613.865 | In distribution | |
| 498.716 | In distribution | |
| 450.147 | In distribution | |
| 489.160 | In distribution | |
| 04.613.812 | In distribution | |
| 450.131 | In distribution | |
| 450.134 | In distribution | |
| 09.633.193 | In distribution | |
| 04.613.813 | In distribution | |
| 04.613.715 | In distribution | |
| 496.778 | In distribution | |
| 498.709 | In distribution | |
| 406.035 | In distribution | |
| 04.613.862 | In distribution | |
| 02.600.006 | In distribution | |
| 04.202.032 | In distribution | |
| 499.905 | In distribution | |
| 04.613.512 | In distribution | |
| 04.613.615 | In distribution | |
| 450.128 | In distribution | |
| 406.016 | In distribution | |
| 04.613.714 | In distribution | |
| 04.613.566 | In distribution | |
| 498.944 | In distribution | |
| 04.613.713 | In distribution | |
| 04.651.440 | In distribution | |
| 04.610.216 | In distribution | |
| 499.235 | In distribution | |
| 04.613.770 | In distribution | |
| 04.651.510 | In distribution | |
| 04.632.317 | In distribution | |
| 04.613.519 | In distribution | |
| 450.146 | In distribution | |
| 498.038 | In distribution | |
| 496.779 | In distribution | |
| 498.452 | In distribution | |
| 498.698 | In distribution | |
| 498.708 | In distribution | |
| 04.613.614 | In distribution | |
| 241.54 | In distribution | |
| 04.613.568 | In distribution | |
| 04.202.024 | In distribution | |
| 04.651.300 | In distribution | |
| 04.201.032 | In distribution | |
| 04.614.624 | In distribution | |
| 298.151 | In distribution | |
| 406.022 | In distribution | |
| 04.616.170 | In distribution | |
| 498.010 | In distribution | |
| 09.636.065 | In distribution | |
| 499.202 | In distribution | |
| 487.04 | In distribution | |
| 498.880 | In distribution | |
| 04.613.816 | In distribution | |
| 04.610.612 | In distribution | |
| 489.154 | In distribution | |
| 04.613.618 | In distribution | |
| 04.613.669 | In distribution | |
| 241.52 | In distribution | |
| 496.780 | In distribution | |
| 241.58 | In distribution | |
| 04.610.112 | In distribution | |
| 04.651.465 | In distribution | |
| 498.011 | In distribution | |
| 499.201 | In distribution | |
| 04.622.355 | In distribution | |
| 04.633.326 | In distribution | |
| 450.133 | In distribution | |
| 04.633.281 | In distribution | |
| 498.876 | In distribution | |
| 498.151 | In distribution | |
| 406.060 | In distribution | |
| 451.012 | In distribution | |
| 489.140 | In distribution | |
| SD298.243 | In distribution | |
| 499.294 | In distribution | |
| 04.633.400 | In distribution | |
| 451.016 | In distribution | |
| 489.170 | In distribution | |
| 498.322 | In distribution | |
| 04.613.820 | In distribution | |
| 298.236 | In distribution | |
| 298.243 | In distribution | |
| 04.633.188 | In distribution | |
| 498.397 | In distribution | |
| 04.613.817 | In distribution | |
| 04.622.354 | In distribution | |
| 298.116 | In distribution | |
| 498.682 | In distribution | |
| 04.613.764 | In distribution | |
| 487.044 | In distribution | |
| 494.681 | In distribution | |
| 450.143 | In distribution | |
| 496.795 | In distribution | |
| 04.202.028 | In distribution | |
| SD04.600.018 | In distribution | |
| 498.285 | In distribution | |
| 04.602.002 | In distribution | |
| 04.651.500 | In distribution | |
| 489.174 | In distribution | |
| 498.292 | In distribution | |
| 04.613.769 | In distribution | |
| 450.142 | In distribution | |
| 498.197 | In distribution | |
| 499.230 | In distribution | |
| 04.613.667 | In distribution | |
| 499.109 | In distribution | |
| 497.796 | In distribution | |
| 496.785 | In distribution | |
| 04.202.026 | In distribution | |
| 04.613.616 | In distribution | |
| 499.111 | In distribution | |
| 04.613.514 | In distribution | |
| 450.132 | In distribution | |
| 04.613.814 | In distribution | |
| 04.613.712 | In distribution | |
| 04.613.666 | In distribution |
Showing 250 of 300 catalogue numbers.
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
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Closed |
|---|---|---|---|---|---|---|
| Synthes USA (HQ), Inc. | 510(k) number | 2011-03-11 | Not classified | Labeling Change Control | Labeling Correction — The locking cap was not able to be loosened, resulting in the breakage of the screwdriver or the rod to be cut and the assembly to be removed (screw, cap, and rod). This poses a potential risk of significant prolonga | 2014-12-18 |
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 |
|---|---|---|---|---|---|
| 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 |
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.