Peek Spacer With X-RAY Markers
38 catalogue numbers from 14-531359, 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
38catalogue 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 | 2015-10-24 |
| Record revised | 2025-01-03 (version 5) |
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, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 14-531359 | C-THRU LORDOTIC 16X14X9MM | In distribution |
| 14-531186 | C-THRU CONVEX 14X12X6MM | In distribution |
| 14-531377 | C-THRU PARALLEL 16X14X7MM | In distribution |
| 14-531370 | C-THRU PARALLEL 12X12X10MM | In distribution |
| 14-531346 | C-THRU LORDOTIC 12X12X6MM | In distribution |
| 14-531352 | C-THRU LORDOTIC 12X12X12MM | In distribution |
| 14-531198 | C-THRU CONVEX 18X16X8MM | In distribution |
| 14-531348 | C-THRU LORDOTIC 12X12X8MM | In distribution |
| 14-531201 | C-THRU CONVEX 18X16X11MM | In distribution |
| 14-531349 | C-THRU LORDOTIC 12X12X9MM | In distribution |
| 14-531366 | C-THRU PARALLEL 12X12X6MM | In distribution |
| 14-531155 | C-THRU LORDOTIC 18X16X5MM | In distribution |
| 14-531176 | C-THRU PARALLEL 18X16X6MM | In distribution |
| 14-531382 | C-THRU PARALLEL 16X14X12MM | In distribution |
| 14-531185 | C-THRU CONVEX 14X12X5MM | In distribution |
| 14-531350 | C-THRU LORDOTIC 12X12X10MM | In distribution |
| 14-531200 | C-THRU CONVEX 18X16X10MM | In distribution |
| 14-531400 | C-THRU CONVEX 16X14X10MM | In distribution |
| 14-531347 | C-THRU LORDOTIC 12X12X7MM | In distribution |
| 14-531152 | C-THRU LORDOTIC 14X12X12MM | In distribution |
| 14-531371 | C-THRU PARALLEL 12X12X11MM | In distribution |
| 14-531378 | C-THRU PARALLEL 16X14X8MM | In distribution |
| 14-531191 | C-THRU CONVEX 14X12X11MM | In distribution |
| 14-531159 | C-THRU LORDOTIC 18X16X9MM | In distribution |
| 14-531369 | C-THRU PARALLEL 12X12X9MM | In distribution |
| 14-531178 | C-THRU PARALLEL 18X16X8MM | In distribution |
| 14-531177 | C-THRU PARALLEL 18X16X7MM | In distribution |
| 14-531181 | C-THRU PARALLEL 18X16X11MM | In distribution |
| 14-531192 | C-THRU CONVEX 14X12X12MM | In distribution |
| 14-531362 | C-THRU LORDOTIC 16X14X12MM | In distribution |
| 14-531167 | C-THRU PARALLEL 14X12X7MM | In distribution |
| 14-531175 | C-THRU PARALLEL 18X16X5MM | In distribution |
| 14-531158 | C-THRU LORDOTIC 18X16X8MM | In distribution |
| 14-531401 | C-THRU CONVEX 16X14X11MM | In distribution |
| 14-531202 | C-THRU CONVEX 18X16X12MM | In distribution |
| 14-531179 | C-THRU PARALLEL 18X16X9MM | In distribution |
| 14-531397 | C-THRU CONVEX 16X14X7MM | In distribution |
| 14-531345 | C-THRU LORDOTIC 12X12X5MM | 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.