FIX-C PEEK Anterior Cervical Interbody System
FIX-C PEEK is an interbody cage system for anterior cervical fusion. The cage occupies the disc space, with its interior packed with autogenous bone graft. The system requires supplemental…
FIX-C PEEK is an interbody cage system for anterior cervical fusion. The cage occupies the disc space, with its interior packed with autogenous bone graft.
The system requires supplemental fixation. Cage sizes and configurations vary to accommodate differences in vertebral level and patient anatomy, rather than providing one universal implant form.
Cervical Application
The intended application is one level from C2 to T1 in skeletally mature patients with degenerative disc disease and accompanying radicular symptoms. The implant is introduced through an anterior approach, with the graft contained inside the cage and separate fixation forming the supported construct.
7manufacturers in China registered for this device type
144catalogue numbers in this listing
2510(k) clearances naming this product code
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) | K212266 |
| Record published | 2022-01-11 |
| Record revised | 2022-01-25 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SC1-PCGS-07 | In distribution | |
| C1-CCGL-06 | In distribution | |
| C1-CCGS-04 | In distribution | |
| SC1-CCGL-08 | In distribution | |
| C1-PCGS-10 | In distribution | |
| C1-LCGS-09 | In distribution | |
| C1-PCGM-11 | In distribution | |
| SC1-PCGM-07 | In distribution | |
| SC1-CCGL-07 | In distribution | |
| C1-LCGS-08 | In distribution | |
| C1-LCGM-07 | In distribution | |
| SC1-PCGM-04 | In distribution | |
| SC1-CCGL-04 | In distribution | |
| C1-LCGM-05 | In distribution | |
| SC1-PCGM-06 | In distribution | |
| C1-LCGS-11 | In distribution | |
| SC1-CCGS-04 | In distribution | |
| C1-PCGL-05 | In distribution | |
| SC1-CCGS-10 | In distribution | |
| SC1-PCGL-08 | In distribution | |
| SC1-CCGM-08 | In distribution | |
| C1-LCGM-09 | In distribution | |
| C1-PCGS-06 | In distribution | |
| C1-PCGS-09 | In distribution | |
| SC1-LCGS-09 | In distribution | |
| C1-PCGM-08 | In distribution | |
| SC1-PCGL-06 | In distribution | |
| C1-PCGM-07 | In distribution | |
| C1-PCGM-10 | In distribution | |
| C1-CCGL-11 | In distribution | |
| C1-LCGL-04 | In distribution | |
| SC1-PCGS-05 | In distribution | |
| C1-LCGM-10 | In distribution | |
| SC1-LCGM-07 | In distribution | |
| SC1-LCGS-04 | In distribution | |
| C1-LCGS-10 | In distribution | |
| SC1-LCGM-09 | In distribution | |
| SC1-CCGM-07 | In distribution | |
| C1-LCGL-09 | In distribution | |
| C1-LCGM-11 | In distribution | |
| C1-LCGS-05 | In distribution | |
| SC1-CCGM-11 | In distribution | |
| C1-PCGL-08 | In distribution | |
| SC1-CCGL-09 | In distribution | |
| SC1-LCGS-11 | In distribution | |
| SC1-LCGM-04 | In distribution | |
| SC1-LCGS-08 | In distribution | |
| C1-PCGL-07 | In distribution | |
| C1-PCGL-09 | In distribution | |
| SC1-LCGL-09 | In distribution | |
| SC1-PCGM-08 | In distribution | |
| C1-LCGL-11 | In distribution | |
| SC1-PCGM-11 | In distribution | |
| C1-CCGS-09 | In distribution | |
| SC1-LCGL-11 | In distribution | |
| SC1-LCGL-06 | In distribution | |
| C1-PCGS-11 | In distribution | |
| C1-PCGL-10 | In distribution | |
| SC1-LCGS-10 | In distribution | |
| C1-CCGL-08 | In distribution | |
| SC1-LCGL-10 | In distribution | |
| C1-PCGL-04 | In distribution | |
| C1-PCGM-04 | In distribution | |
| SC1-CCGL-10 | In distribution | |
| C1-PCGL-06 | In distribution | |
| C1-LCGS-07 | In distribution | |
| C1-CCGL-09 | In distribution | |
| C1-CCGM-05 | In distribution | |
| C1-PCGS-04 | In distribution | |
| C1-LCGL-07 | In distribution | |
| SC1-CCGM-09 | In distribution | |
| SC1-PCGS-11 | In distribution | |
| C1-LCGS-04 | In distribution | |
| C1-LCGM-06 | In distribution | |
| C1-CCGS-07 | In distribution | |
| SC1-PCGM-05 | In distribution | |
| SC1-LCGL-08 | In distribution | |
| SC1-CCGS-06 | In distribution | |
| C1-LCGM-04 | In distribution | |
| C1-CCGM-11 | In distribution | |
| SC1-CCGL-06 | In distribution | |
| C1-PCGS-05 | In distribution | |
| SC1-CCGL-11 | In distribution | |
| SC1-LCGL-04 | In distribution | |
| C1-CCGM-10 | In distribution | |
| C1-LCGL-08 | In distribution | |
| SC1-PCGS-10 | In distribution | |
| C1-LCGM-08 | In distribution | |
| SC1-CCGS-11 | In distribution | |
| SC1-LCGM-06 | In distribution | |
| SC1-PCGL-09 | In distribution | |
| C1-PCGM-09 | In distribution | |
| SC1-LCGS-07 | In distribution | |
| SC1-LCGM-08 | In distribution | |
| C1-LCGL-10 | In distribution | |
| SC1-CCGM-06 | In distribution | |
| SC1-LCGL-07 | In distribution | |
| C1-CCGM-07 | In distribution | |
| SC1-LCGM-11 | In distribution | |
| SC1-PCGS-08 | In distribution | |
| SC1-CCGL-05 | In distribution | |
| C1-CCGS-05 | In distribution | |
| SC1-CCGS-08 | In distribution | |
| C1-PCGM-06 | In distribution | |
| SC1-CCGM-10 | In distribution | |
| C1-CCGL-05 | In distribution | |
| SC1-LCGM-05 | In distribution | |
| C1-PCGM-05 | In distribution | |
| C1-CCGM-09 | In distribution | |
| SC1-PCGS-09 | In distribution | |
| SC1-PCGM-10 | In distribution | |
| C1-CCGS-08 | In distribution | |
| C1-PCGS-08 | In distribution | |
| C1-CCGL-10 | In distribution | |
| C1-CCGL-07 | In distribution | |
| SC1-PCGL-10 | In distribution | |
| C1-LCGS-06 | In distribution | |
| SC1-LCGS-05 | In distribution | |
| SC1-PCGM-09 | In distribution | |
| SC1-PCGL-05 | In distribution | |
| SC1-LCGL-05 | In distribution | |
| SC1-CCGS-07 | In distribution | |
| C1-CCGM-04 | In distribution | |
| SC1-CCGM-05 | In distribution | |
| SC1-CCGM-04 | In distribution | |
| SC1-PCGS-04 | In distribution | |
| C1-LCGL-05 | In distribution | |
| SC1-PCGL-11 | In distribution | |
| C1-CCGL-04 | In distribution | |
| C1-LCGL-06 | In distribution | |
| C1-CCGS-10 | In distribution | |
| C1-PCGL-11 | In distribution | |
| SC1-PCGL-04 | In distribution | |
| SC1-LCGS-06 | In distribution | |
| C1-CCGS-06 | In distribution | |
| C1-CCGM-08 | In distribution | |
| SC1-PCGS-06 | In distribution | |
| SC1-PCGL-07 | In distribution | |
| SC1-LCGM-10 | In distribution | |
| SC1-CCGS-05 | In distribution | |
| SC1-CCGS-09 | In distribution | |
| C1-CCGS-11 | In distribution | |
| C1-PCGS-07 | In distribution | |
| C1-CCGM-06 | 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.