C-Fuse® Cervical Intervertebral Body Fusion System
C-Fuse is a trapezoidal cervical interbody cage with machined grooves on its upper and lower surfaces. A hollow central core accepts autogenous bone graft for fusion between adjacent…
C-Fuse is a trapezoidal cervical interbody cage with machined grooves on its upper and lower surfaces. A hollow central core accepts autogenous bone graft for fusion between adjacent vertebrae.
The device uses Zeniva ZA-500 PEEK and tantalum wire. Instruments assist placement of the spacer through an anterior approach.
Listed Item
Cervical Cage, 16mm X 13mm X 11mm
Cervical Construct and Preparation
The single-use implants are supplied nonsterile, with reusable nonsterile instruments and a tray for steam sterilization. The system requires supplemental fixation and is intended for a single cervical disc level from C3 to C7 in skeletally mature patients.
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 | Southern Spine, LLC, United States |
|---|---|
| FDA product code | ODP |
| Device type | Intervertebral Fusion Device With Bone Graft, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K130948 |
| Record published | 2016-07-20 |
| Record revised | 2022-09-16 (version 9) |
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 |
|---|---|---|
| MA-665 | In distribution | |
| TY-0703 | In distribution | |
| RA-660 | In distribution | |
| C1412-6 | In distribution | |
| TY-0700 | In distribution | |
| C1613-7 | In distribution | |
| C1412-7 | In distribution | |
| C1613-6 | In distribution | |
| TR-651 | In distribution | |
| TR-642 | In distribution | |
| TR-645 | In distribution | |
| TR-646 | In distribution | |
| EX-680 | In distribution | |
| C1814-6 | In distribution | |
| C1613-11 | In distribution | |
| C1613-10 | In distribution | |
| TR-649 | In distribution | |
| TR-648 | In distribution | |
| C1814-11 | In distribution | |
| C1613-5 | In distribution | |
| C1814-7 | In distribution | |
| C1412-8 | In distribution | |
| TY-0701 | In distribution | |
| TR-647 | In distribution | |
| C1412-5 | In distribution | |
| TY-0702 | In distribution | |
| C1814-8 | In distribution | |
| TR-650 | In distribution | |
| C1814-12 | In distribution | |
| IT-670 | In distribution | |
| C1412-9 | In distribution | |
| C1814-9 | In distribution | |
| C1613-12 | In distribution | |
| C1814-10 | In distribution | |
| C1412-10 | In distribution | |
| C1412-11 | In distribution | |
| C1814-5 | In distribution | |
| TR-641 | In distribution | |
| TR-652 | In distribution | |
| TA-690 | In distribution | |
| TR-643 | In distribution | |
| C1613-9 | In distribution | |
| TR-644 | In distribution | |
| C1613-8 | In distribution | |
| C1412-12 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K130948 | 2013-08-14 |
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.