CarboClear Cervical VBR System
A cervical spine vertebral body replacement device
1manufacturer
31catalogue numbers in this listing
Who Else Makes It
Registered in Shandong. 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 |
Record
| Listed by | CarboFix Orthopedics, Ltd., Israel |
|---|---|
| FDA product code | PLR |
| Device type | Spinal Vertebral Body Replacement Device – Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Manufacturer |
| 510(k) | K222874 |
| Record published | 2023-10-02 |
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 | Height 16 to 44 mm; width 14 to 16 mm; depth 12 to 14 mm; angle 0 to 8 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VBR Spacer | Height 22 mm | In distribution |
| VBR Spacer | Height 26 mm | In distribution |
| VBR Spacer | Height 16 mm | In distribution |
| VBR Spacer | Height 20 mm | In distribution |
| VBR Spacer | Height 24 mm | In distribution |
| VBR Spacer | Height 20 mm | In distribution |
| VBR Spacer | Height 32 mm | In distribution |
| VBR Spacer | Height 42 mm | In distribution |
| VBR Spacer | Height 18 mm | In distribution |
| VBR Spacer | Height 20 mm | In distribution |
| VBR Spacer | Height 16 mm | In distribution |
| VBR Spacer | Height 22 mm | In distribution |
| VBR Spacer | Height 32 mm | In distribution |
| VBR Spacer | Height 18 mm | In distribution |
| VBR Spacer | Height 24 mm | In distribution |
| VBR Spacer | Height 44 mm | In distribution |
| VBR Spacer | Height 18 mm | In distribution |
| VBR Spacer | Height 30 mm | In distribution |
| VBR Spacer | Height 26 mm | In distribution |
| VBR Spacer | Height 24 mm | In distribution |
| VBR Spacer | Height 28 mm | In distribution |
| VBR Spacer | Height 36 mm | In distribution |
| VBR Spacer | Height 26 mm | In distribution |
| VBR Spacer | Height 26 mm | In distribution |
| VBR Spacer | Height 34 mm | In distribution |
| VBR Spacer | Height 20 mm | In distribution |
| VBR Spacer | Height 40 mm | In distribution |
| VBR Spacer | Height 30 mm | In distribution |
| VBR Spacer | Height 22 mm | In distribution |
| VBR Spacer | Height 38 mm | In distribution |
| VBR Spacer | Height 28 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Alta | Astura Medical | 290 |
| Ascend | Alphatec Spine, Inc. | 267 |
| Matrixx System | Nexxt Spine LLC | 88 |
| Colosseum | Globus Medical, Inc. | 87 |
| Palo Alto Corpectomy Cage System | VB Spine LLC | 56 |
| C-VBR | VB Spine LLC | 53 |
| Trabis® | Coligne AG | 34 |
| X-Core | Nuvasive, Inc. | 31 |
| Capri™ Corpectomy Cage System | VB Spine LLC | 25 |
| Zavation | Zavation | 25 |
| Verteloc Spinal System | Signature Orthopaedics PTY Limited | 17 |
| Fortify | Globus Medical, Inc. | 14 |
Showing 12 of 31. All products under Spinal Vertebral Body Replacement Device – Cervical
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.