CarboClear Posterior Cervical Screw System
Titanium Alloy Straight Rod of the CarboClear Posterior Cervical Screw System
7manufacturers in China registered for this device type
53catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Shandong (2), Zhejiang (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
| Shanghai Sanyou Medical Co., Ltd. | Shanghai | Shanghai | Manufacturer | 6 |
Record
| Listed by | CarboFix Orthopedics, Ltd., Israel |
|---|---|
| FDA product code | ODP |
| Device type | Intervertebral Fusion Device With Bone Graft, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Manufacturer |
| 510(k) | K233989 |
| Record published | 2024-06-05 |
| Record revised | 2025-07-14 (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 |
| Packaging | Pack of 2 |
| Sizes | Length 12 to 200 mm; outer diameter 4 to 5 mm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Straight Rod | Length 200 mm | In distribution | |
| Screw | Length 24 mm | In distribution | |
| Screw | Length 40 mm | In distribution | |
| Locking Element | 2 | In distribution | |
| Screw | Length 20 mm | In distribution | |
| Screw | Length 18 mm | In distribution | |
| Screw | Length 22 mm | In distribution | |
| Straight Rod | Length 80 mm | 2 | In distribution |
| Screw | Length 12 mm | In distribution | |
| Screw | Length 38 mm | In distribution | |
| Cervical Screw | Length 15 mm | In distribution | |
| Screw | Length 28 mm | In distribution | |
| Straight Rod | Length 90 mm | 2 | In distribution |
| Screw | Length 26 mm | In distribution | |
| Curved Rod | Length 60 mm | 2 | In distribution |
| Screw | Length 14 mm | In distribution | |
| Screw | Length 38 mm | In distribution | |
| Curved Rod | Length 50 mm | 2 | In distribution |
| Screw | Length 30 mm | In distribution | |
| Straight Rod | Length 40 mm | 2 | In distribution |
| Screw | Length 30 mm | In distribution | |
| Screw | Length 36 mm | In distribution | |
| Screw | Length 16 mm | In distribution | |
| Screw | Length 18 mm | In distribution | |
| Curved Rod | Length 70 mm | 2 | In distribution |
| Screw | Length 36 mm | In distribution | |
| Curved Rod | Length 90 mm | 2 | In distribution |
| Screw | Length 26 mm | In distribution | |
| Screw | Length 32 mm | In distribution | |
| Screw | Length 32 mm | In distribution | |
| Cervical Screw | Outer Diameter 5.0 mm | In distribution | |
| Screw | Length 14 mm | In distribution | |
| Screw | Length 20 mm | In distribution | |
| Screw | Length 28 mm | In distribution | |
| Straight Rod | Length 60 mm | 2 | In distribution |
| Ti Rod | Length 200 mm | In distribution | |
| Curved Rod | Length 100 mm | 2 | In distribution |
| Curved Rod | Length 200 mm | In distribution | |
| Screw | Length 12 mm | In distribution | |
| Screw | Length 34 mm | In distribution | |
| Straight Rod | Length 100 mm | 2 | In distribution |
| Curved Rod | Length 80 mm | 2 | In distribution |
| Screw | Length 34 mm | In distribution | |
| Straight Rod | Length 70 mm | 2 | In distribution |
| Screw | Length 22 mm | In distribution | |
| Screw | Length 24 mm | In distribution | |
| Cervical Screw | Length 20 mm | In distribution | |
| Screw | Length 40 mm | In distribution | |
| Straight Rod | Length 30 mm | 2 | In distribution |
| Curved Rod | Length 40 mm | 2 | In distribution |
| Curved Rod | Length 30 mm | 2 | In distribution |
| Straight Rod | Length 50 mm | 2 | In distribution |
| Screw | Length 16 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Latitude-C AM™ Cervical Interbody Fusion System | Degen Medical | 1,529 |
| IdentiTi | Alphatec Spine, Inc. | 1,390 |
| Zavation | Zavation | 1,357 |
| IVA Cage Ti | Diomedical Co., Ltd. | 1,202 |
| Latitude-C Cervical Interbody Spacer System | Degen Medical | 1,185 |
| Peridot Anterior Cervical Intervertebral Body Fusion System | Gbs Commonwealth Co., Ltd. | 1,056 |
| Aleutian® Interbody Systems | VB Spine LLC | 1,017 |
| Valeo Spacer System | Sintx Technologies Inc. | 918 |
| Cascadia™ Interbody System | VB Spine LLC | 823 |
| CoRoent | Nuvasive, Inc. | 815 |
| Tyber Medical | Tyber Medical | 740 |
| Matisse Anterior Cervical Interbody Fusion Cage System | CTL Medical Corporation | 577 |
Showing 12 of 938. All products under Intervertebral Fusion Device With Bone Graft, 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.