CarboClear Vertebral Body Replacement System
Handle for use with the CarboClear VBR (vertebral body replacement) System
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 | CarboFix Orthopedics, Ltd., Israel |
|---|---|
| FDA product code | MQP |
| Device type | Spinal Vertebral Body Replacement Device |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Manufacturer |
| 510(k) | K192214 |
| Record published | 2019-11-07 |
| Record revised | 2020-10-19 (version 3) |
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 |
| Sizes | Outer diameter 22 to 35 mm; height 30 to 85 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VBR Spacer | Height 65 mm | In distribution |
| VBR Spacer | Height 85 mm | In distribution |
| VBR Spacer | Height 35 mm | In distribution |
| VBR Spacer | Height 75 mm | In distribution |
| VBR Insertion Handle | In distribution | |
| VBR Spacer | Height 60 mm | In distribution |
| VBR Spacer | Height 75 mm | In distribution |
| VBR Spacer | Height 50 mm | In distribution |
| VBR Spacer | Height 45 mm | In distribution |
| VBR Spacer | Height 65 mm | In distribution |
| VBR Spacer | Height 50 mm | In distribution |
| VBR Spacer | Height 85 mm | In distribution |
| VBR Spacer | Height 60 mm | In distribution |
| Patient Specific VBR Spacer | In distribution | |
| VBR Spacer | Height 85 mm | In distribution |
| VBR Spacer | Height 80 mm | In distribution |
| VBR Spacer | Height 55 mm | In distribution |
| VBR Spacer | Height 80 mm | In distribution |
| VBR Spacer | Outer Diameter 25 mm | In distribution |
| VBR Spacer | Height 65 mm | In distribution |
| VBR Spacer | Height 70 mm | In distribution |
| VBR Spacer | Height 40 mm | In distribution |
| VBR Spacer | Outer Diameter 25 mm | In distribution |
| VBR Spacer | Height 60 mm | In distribution |
| VBR Spacer | Height 35 mm | In distribution |
| VBR Spacer | Height 30 mm | In distribution |
| VBR Spacer | Height 45 mm | In distribution |
| VBR Spacer | Height 70 mm | In distribution |
| VBR Spacer | Height 70 mm | In distribution |
| VBR Spacer | Height 55 mm | In distribution |
| VBR Spacer | Height 40 mm | In distribution |
| VBR Spacer | Height 45 mm | In distribution |
| VBR Spacer | Height 35 mm | In distribution |
| VBR Spacer | Height 50 mm | In distribution |
| VBR Spacer | Height 80 mm | In distribution |
| VBR Spacer | Height 75 mm | In distribution |
| VBR Spacer | Outer Diameter 27.5 mm | In distribution |
| VBR Spacer | Height 55 mm | 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 |
|---|---|
| K192214 | 2019-10-11 |
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.