C-Thru™ Anterior Spinal System
56 catalogue numbers from 55001965, listed by Biomet Spine, United States, under Spinal Vertebral Body Replacement Device. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
56catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Shanghai (1), Jiangsu (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Biomet Spine, United States |
|---|---|
| FDA product code | MQP |
| Device type | Spinal Vertebral Body Replacement Device |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Record published | 2021-07-23 |
| Record revised | 2025-01-03 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 55001965 | Convex 11 x 11 x 5 mm PEEK Spacer with X-Ray Marker | In distribution |
| 14-531382 | Parallel 16 x 14 x 12 mm PEEK Spacer with X-Ray Markers | In distribution |
| 14-531359 | Lordotic 16 x 14 x 9 mm PEEK Spacer with X-Ray Markers | In distribution |
| 14-531177 | Parallel 18 x 16 x 7 mm PEEK Spacer with X-Ray Markers | In distribution |
| 14-531196 | Convex 18 x 16 x 6 mm PEEK Spacer with X-Ray Markers | In distribution |
| 14-531165 | Parallel 14 x 12 x 5 mm PEEK Spacer with X-Ray Markers | In distribution |
| 14-531400 | Convex 16 x 14 x 10 mm PEEK Spacer with X-Ray Markers | In distribution |
| 14-531398 | Convex 16 x 14 x 8 mm PEEK Spacer with X-Ray Markers | In distribution |
| 14-531191 | Convex 14 x 12 x 11 mm PEEK Spacer with X-Ray Markers | In distribution |
| 14-531152 | Lordotic 14 x 12 x 12 mm PEEK Spacer with X-Ray Markers | In distribution |
| 55001906 | Lordotic 11 x 11 x 6 mm PEEK Spacer with X-Ray Markers | In distribution |
| 14-531166 | Parallel 14 x 12 x 6 mm PEEK Spacer with X-Ray Markers | In distribution |
| 14-531192 | Convex 14 x 12 x 12 mm PEEK Spacer with X-Ray Markers | In distribution |
| 14-531378 | Parallel 16 x 14 x 8 mm PEEK Spacer with X-Ray Markers | In distribution |
| 14-531190 | Convex 14 x 12 x 10 mm PEEK Spacer with X-Ray Markers | In distribution |
| 55001910 | Lordotic 11 x 11 x 10 mm PEEK Spacer with X-Ray Markers | In distribution |
| 14-531365 | Parallel 12 x 12 x 5 mm PEEK Spacer with X-Ray Markers | In distribution |
| 14-531395 | Convex 16 x 14 x 5 mm PEEK Spacer with X-Ray Markers | In distribution |
| 14-531180 | Parallel 18 x 16 x 10 mm PEEK Spacer with X-Ray Markers | In distribution |
| 14-531185 | Convex 14 x 12 x 5 mm PEEK Spacer with X-Ray Markers | In distribution |
| 14-531200 | Convex 18 x 16 x 10 mm PEEK Spacer with X-Ray Markers | In distribution |
| 14-531367 | Parallel 12 x 12 x 7 mm PEEK Spacer with X-Ray Markers | In distribution |
| 14-531151 | Lordotic 14 x 12 x 11 mm PEEK Spacer with X-Ray Markers | In distribution |
| 14-531189 | Convex 14 x 12 x 9 mm PEEK Spacer with X-Ray Markers | In distribution |
| 14-531160 | Lordotic 18 x 16 x 10 mm PEEK Spacer with X-Ray Markers | In distribution |
| 14-531149 | Lordotic 14 x 12 x 9 mm PEEK Spacer with X-Ray Markers | In distribution |
| 14-531158 | Lordotic 18 x 16 x 8 mm PEEK Spacer with X-Ray Markers | In distribution |
| 55001941 | Parallel 11 x 11 x 11 mm PEEK Spacer with X-Ray Marker | In distribution |
| 14-531360 | Lordotic 16 x 14 x 10 mm PEEK Spacer with X-Ray Markers | In distribution |
| 14-531377 | Parallel 16 x 14 x 7 mm PEEK Spacer with X-Ray Markers | In distribution |
| 14-531199 | Convex 18 x 16 x 9 mm PEEK Spacer with X-Ray Markers | In distribution |
| 14-531370 | Parallel 12 x 12 x 10 mm PEEK Spacer with X-Ray Markers | In distribution |
| 55001912 | Lordotic 11 x 11 x 12 mm PEEK Spacer with X-Ray Markers | In distribution |
| 14-531169 | Parallel 14 x 12 x 9 mm PEEK Spacer with X-Ray Markers | In distribution |
| 14-531392 | Convex 12 x 12 x 12 mm PEEK Spacer with X-Ray Markers | In distribution |
| 14-531186 | Convex 14 x 12 x 6 mm PEEK Spacer with X-Ray Markers | In distribution |
| 14-531357 | Lordotic 16 x 14 x 7 mm PEEK Spacer with X-Ray Markers | In distribution |
| 14-531162 | Lordotic 18 x 16 x 12 mm PEEK Spacer with X-Ray Markers | In distribution |
| 55001968 | Convex 11 x 11 x 8 mm PEEK Spacer with X-Ray Marker | In distribution |
| 14-531371 | Parallel 12 x 12 x 11 mm PEEK Spacer with X-Ray Markers | In distribution |
| 14-531399 | Convex 16 x 14 x 9 mm PEEK Spacer with X-Ray Markers | In distribution |
| 14-531175 | Parallel 18 x 16 x 5 mm PEEK Spacer with X-Ray Markers | In distribution |
| 55001967 | Convex 11 x 11 x 7 mm PEEK Spacer with X-Ray Marker | In distribution |
| 14-531156 | Lordotic 18 x 16 x 6 mm PEEK Spacer with X-Ray Markers | In distribution |
| 55001966 | Convex 11 x 11 x 6 mm PEEK Spacer with X-Ray Marker | In distribution |
| 55001938 | Parallel 11 x 11 x 8 mm PEEK Spacer with X-Ray Marker | In distribution |
| 14-531362 | Lordotic 16 x 14 x 12 mm PEEK Spacer with X-Ray Markers | In distribution |
| 14-531396 | Convex 16 x 14 x 6 mm PEEK Spacer with X-Ray Markers | In distribution |
| 14-531355 | Lordotic 16 x 14 x 5 mm PEEK Spacer with X-Ray Markers | In distribution |
| 14-531361 | Lordotic 16 x 14 x 11 mm PEEK Spacer with X-Ray Markers | In distribution |
| 14-531350 | Lordotic 12 x 12 x 10 mm PEEK Spacer with X-Ray Markers | In distribution |
| 14-531347 | Lordotic 12 x 12 x 7 mm PEEK Spacer with X-Ray Markers | In distribution |
| 14-531372 | Parallel 12 x 12 x 12 mm PEEK Spacer with X-Ray Markers | In distribution |
| 14-531195 | Convex 18 x 16 x 5 mm PEEK Spacer with X-Ray Markers | In distribution |
| 14-531351 | Lordotic 12 x 12 x 11 mm PEEK Spacer with X-Ray Markers | In distribution |
| 14-531197 | Convex 18 x 16 x 7 mm PEEK Spacer with X-Ray Markers | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CoRoent | Nuvasive, Inc. | 1,514 |
| Capri™ Corpectomy Cage System | VB Spine LLC | 1,509 |
| Aleutian® Interbody Systems | VB Spine LLC | 1,189 |
| Fortify | Globus Medical, Inc. | 866 |
| Matrixx System | Nexxt Spine LLC | 748 |
| Ascend | Alphatec Spine, Inc. | 555 |
| Zavation VBR Trial | Zavation | 548 |
| Verte-Stack® Spinal System | Medtronic Sofamor Danek, Inc. | 484 |
| Timberline® Lateral Interbody Fusion System | Biomet Spine | 470 |
| Timberline Lateral Fusion System | Biomet Spine | 459 |
| Novel | Alphatec Spine, Inc. | 447 |
| Hawkeye™ Vertebral Body Replacement (VBR) | Choice Spine, LP | 368 |
Showing 12 of 683. All products under Spinal Vertebral Body Replacement Device
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K063393 | 2007-06-25 |
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.