Solitaire™ Anterior Spinal System
36 catalogue numbers from 1400-1206, 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
36catalogue 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 | 2025-07-02 (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 |
|---|---|---|
| 1400-1206 | SOLITAIRE NARROW 16MM / 12° | In distribution |
| 1400-0056 | SOLITAIRE WIDE 16MM / 0° | In distribution |
| 1400-0006 | SOLITAIRE NARROW 16MM / 0° | In distribution |
| 1400-1236 | SOLITAIRE MEDIUM 16MM / 12° | In distribution |
| 1400-1232 | SOLITAIRE MEDIUM 12MM / 12° | In distribution |
| 1400-1256 | SOLITAIRE WIDE 16MM / 12° | In distribution |
| 14-530110 | SOLITAIRE PENTALOBE SCREW 24MM | In distribution |
| 1400-0652 | SOLITAIRE WIDE 12MM / 6° | In distribution |
| 1400-1234 | SOLITAIRE MEDIUM 14MM / 12° | In distribution |
| 1400-0606 | SOLITAIRE NARROW 16MM / 6° | In distribution |
| 1400-0059 | SOLITAIRE WIDE 20MM / 0° | In distribution |
| 1400-1252 | SOLITAIRE WIDE 12MM / 12° | In distribution |
| 1400-1013 | AFD 5.5MM X 35MM SCREW | In distribution |
| 1400-0058 | SOLITAIRE WIDE 18MM / 0° | In distribution |
| 1400-1012 | AFD 5.5MM X 30MM SCREW | In distribution |
| 1400-0004 | SOLITAIRE NARROW 14MM / 0° | In distribution |
| 1400-0608 | SOLITAIRE NARROW 18MM / 6° | In distribution |
| 1400-0636 | SOLITAIRE MEDIUM 16MM / 6° | In distribution |
| 1400-0632 | SOLITAIRE MEDIUM 12MM / 6° | In distribution |
| 1400-0639 | SOLITAIRE MEDIUM 20MM / 6° | In distribution |
| 1400-0050 | SOLITAIRE WIDE 10MM / 0° | In distribution |
| 1400-0036 | SOLITAIRE MEDIUM 16MM / 0° | In distribution |
| 1400-1011 | AFD 5.5MM X 25MM SCREW | In distribution |
| 1400-0032 | SOLITAIRE MEDIUM 12MM / 0° | In distribution |
| 1400-0654 | SOLITAIRE WIDE 14MM / 6° | In distribution |
| 14-530111 | SOLITAIRE PENTALOBE SCREW 25MM | In distribution |
| 14-530121 | SOLITAIRE PENTALOBE SCREW 35MM | In distribution |
| 14-530117 | SOLITAIRE PENTALOBE SCREW 31MM | In distribution |
| 1400-1250 | SOLITAIRE WIDE 10MM / 12° | In distribution |
| 14-530112 | SOLITAIRE PENTALOBE SCREW 26MM | In distribution |
| 1400-1238 | SOLITAIRE MEDIUM 18MM / 12° | In distribution |
| 14-530113 | SOLITAIRE PENTALOBE SCREW 27MM | In distribution |
| 1400-0604 | SOLITAIRE NARROW 14MM / 6° | In distribution |
| 1400-1200 | SOLITAIRE NARROW 10MM / 12° | In distribution |
| 1400-0030 | SOLITAIRE MEDIUM 10MM / 0° | In distribution |
| 1400-1209 | SOLITAIRE NARROW 20MM / 12° | 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.