Cslp
TI Cervical Spine Locking PL Variable Angle 4 LEVEL/100MM
14manufacturers in China registered for this device type
92catalogue 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 |
| Record published | 2015-09-14 |
| Record revised | 2025-11-20 (version 5) |
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 |
|---|---|---|
| 450.124 | In distribution | |
| 450.187 | In distribution | |
| 487.215 | In distribution | |
| 450.181 | In distribution | |
| 450.228 | In distribution | |
| 450.354 | In distribution | |
| 450.154 | In distribution | |
| 450.157 | In distribution | |
| 487.226 | In distribution | |
| 487.212 | In distribution | |
| 450.237 | In distribution | |
| 450.171 | In distribution | |
| 450.484 | In distribution | |
| 450.155 | In distribution | |
| 450.472 | In distribution | |
| 450.182 | In distribution | |
| 487.359 | In distribution | |
| 450.188 | In distribution | |
| 450.464 | In distribution | |
| 450.166 | In distribution | |
| 450.360 | In distribution | |
| 450.162 | In distribution | |
| 450.191 | In distribution | |
| 450.363 | In distribution | |
| 450.122 | In distribution | |
| 450.152 | In distribution | |
| 487.351 | In distribution | |
| 487.214 | In distribution | |
| 487.216 | In distribution | |
| 450.348 | In distribution | |
| 487.237 | In distribution | |
| 450.172 | In distribution | |
| 487.227 | In distribution | |
| 450.184 | In distribution | |
| 450.114 | In distribution | |
| 450.234 | In distribution | |
| 450.156 | In distribution | |
| 450.460 | In distribution | |
| 450.120 | In distribution | |
| 450.116 | In distribution | |
| 487.238 | In distribution | |
| 487.345 | In distribution | |
| 450.246 | In distribution | |
| 487.218 | In distribution | |
| 450.173 | In distribution | |
| 450.243 | In distribution | |
| 450.174 | In distribution | |
| 450.126 | In distribution | |
| 450.185 | In distribution | |
| 487.342 | In distribution | |
| 487.348 | In distribution | |
| 450.366 | In distribution | |
| 450.151 | In distribution | |
| 450.369 | In distribution | |
| 487.355 | In distribution | |
| 450.189 | In distribution | |
| 487.357 | In distribution | |
| 450.186 | In distribution | |
| 450.476 | In distribution | |
| 487.223 | In distribution | |
| 450.240 | In distribution | |
| 450.163 | In distribution | |
| 450.167 | In distribution | |
| 487.213 | In distribution | |
| 450.153 | In distribution | |
| 450.164 | In distribution | |
| 487.217 | In distribution | |
| 487.354 | In distribution | |
| 450.118 | In distribution | |
| 450.345 | In distribution | |
| 487.358 | In distribution | |
| 487.228 | In distribution | |
| 450.183 | In distribution | |
| 450.175 | In distribution | |
| 450.190 | In distribution | |
| 450.231 | In distribution | |
| 450.179 | In distribution | |
| 450.165 | In distribution | |
| 450.351 | In distribution | |
| 450.176 | In distribution | |
| 450.357 | In distribution | |
| 487.339 | In distribution | |
| 487.225 | In distribution | |
| 450.161 | In distribution | |
| 487.222 | In distribution | |
| 487.224 | In distribution | |
| 450.468 | In distribution | |
| 450.480 | In distribution | |
| 450.178 | In distribution | |
| 487.356 | In distribution | |
| 487.236 | In distribution | |
| 450.177 | 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
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.