FIX-C 3d Ti Acif System
FIX-C 3D Ti Acif System comprises porous titanium cages for anterior cervical interbody fusion. Selective laser melting creates solid and porous regions in Ti-6Al-4V ELI alloy. The hollow…
FIX-C 3D Ti Acif System comprises porous titanium cages for anterior cervical interbody fusion. Selective laser melting creates solid and porous regions in Ti-6Al-4V ELI alloy. The hollow cage can be packed with bone graft.
The system treats skeletally mature patients with imaging-confirmed cervical disc degeneration or instability producing radiculopathy, myelopathy or pain at one or more contiguous levels from C2 to T1. Patients should have received at least six weeks of nonoperative treatment.
Placement Requirements
The cages require supplemental cervical spinal fixation and autogenous or allogeneic cancellous or corticocancellous bone graft. They come in standard sizes, footprints, heights and angles rather than patient-matched forms. Devices are supplied nonsterile and require sterilization before use.
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 | Jeil Medical Corporation, South Korea |
|---|---|
| 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) | K243915 |
| Record published | 2025-03-03 |
| Record revised | 2025-07-14 (version 2) |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| C73-001516-04 | In distribution | |
| C73-001314-11 | In distribution | |
| C73-051314-11 | In distribution | |
| C73-001516-05 | In distribution | |
| C73-001314-07 | In distribution | |
| C73-071112-05 | In distribution | |
| C73-001112-04 | In distribution | |
| C73-071314-08 | In distribution | |
| C73-051314-08 | In distribution | |
| C73-051112-07 | In distribution | |
| C73-051516-08 | In distribution | |
| C73-001112-08 | In distribution | |
| C73-001112-06 | In distribution | |
| C73-001112-11 | In distribution | |
| C73-051314-10 | In distribution | |
| C73-001516-09 | In distribution | |
| C73-071112-11 | In distribution | |
| C73-051112-09 | In distribution | |
| C73-001314-05 | In distribution | |
| C73-001112-09 | In distribution | |
| C73-071516-09 | In distribution | |
| C73-001112-07 | In distribution | |
| C73-071516-06 | In distribution | |
| C73-001516-06 | In distribution | |
| C73-051314-04 | In distribution | |
| C73-071112-07 | In distribution | |
| C73-051516-09 | In distribution | |
| C73-071314-09 | In distribution | |
| C73-051516-07 | In distribution | |
| C73-051314-07 | In distribution | |
| C73-001314-08 | In distribution | |
| C73-071314-07 | In distribution | |
| C73-071112-04 | In distribution | |
| C73-071516-07 | In distribution | |
| C73-071314-11 | In distribution | |
| C73-071516-04 | In distribution | |
| C73-001516-11 | In distribution | |
| C73-051516-06 | In distribution | |
| C73-071112-09 | In distribution | |
| C73-071314-04 | In distribution | |
| C73-051112-08 | In distribution | |
| C73-051112-11 | In distribution | |
| C73-051314-09 | In distribution | |
| C73-051112-05 | In distribution | |
| C73-071112-08 | In distribution | |
| C73-001516-07 | In distribution | |
| C73-001314-06 | In distribution | |
| C73-051314-05 | In distribution | |
| C73-001314-09 | In distribution | |
| C73-001516-10 | In distribution | |
| C73-051314-06 | In distribution | |
| C73-071112-10 | In distribution | |
| C73-001314-04 | In distribution | |
| C73-051112-06 | In distribution | |
| C73-001516-08 | In distribution | |
| C73-051112-04 | In distribution | |
| C73-001112-05 | In distribution | |
| C73-071516-08 | In distribution | |
| C73-071112-06 | In distribution | |
| C73-051516-11 | In distribution | |
| C73-001314-10 | In distribution | |
| C73-051516-05 | In distribution | |
| C73-051516-10 | In distribution | |
| C73-071516-05 | In distribution | |
| C73-071516-11 | In distribution | |
| C73-051516-04 | In distribution | |
| C73-071314-05 | In distribution | |
| C73-051112-10 | In distribution | |
| C73-071516-10 | In distribution | |
| C73-001112-10 | In distribution | |
| C73-071314-06 | In distribution | |
| C73-071314-10 | 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 |
|---|---|
| K243915 | 2025-02-18 |
| K212266 | 2021-12-21 |
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.