Stalif C
STALIF C is a cervical interbody fusion cage that combines a radiolucent PEEK body with titanium alloy bone screws. It is placed in the disc space between adjacent vertebral bodies and used…
STALIF C is a cervical interbody fusion cage that combines a radiolucent PEEK body with titanium alloy bone screws. It is placed in the disc space between adjacent vertebral bodies and used as a standalone construct without additional supplemental fixation.
The cage’s outline follows the vertebral endplate, and its central cavity is packed with the patient’s own bone graft. Unalloyed tantalum marker wires make the cage position visible on radiographs.
Fusion Construct
The PEEK-OPTIMA LT1 cage and its unicortical cancellous-bone screws work together as the fusion device. STALIF C is intended for a single cervical level from C2 to T1 in skeletally mature patients with cervical degenerative disc disease.
Who Else Makes It
Concentrated in Zhejiang (2), Guangdong (1), Jiangsu (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Centinel Spine, LLC, United States |
|---|---|
| FDA product code | OVE |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K120819 |
| Record published | 2017-03-13 |
| Record revised | 2026-05-21 (version 4) |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| C169579-3T | In distribution | |
| C165538-2T | In distribution | |
| C165539-3T | In distribution | |
| C148571-3D | In distribution | |
| C145541-3D-I | In distribution | |
| C141210-3D | In distribution | |
| RAB1740 | In distribution | |
| ABS1340 | In distribution | |
| C149581-3D | In distribution | |
| C146551-3D | In distribution | |
| RAB1340 | In distribution | |
| C146551-3D-I | In distribution | |
| C125541-3D | In distribution | |
| C147561-3D-I | In distribution | |
| C169579-3D | In distribution | |
| C147561-3D | In distribution | |
| C161189-3T | In distribution | |
| C126551-3T | In distribution | |
| C166549-3T | In distribution | |
| C129581-3D | In distribution | |
| ABS1540 | In distribution | |
| ABS1440 | In distribution | |
| C125541-3T | In distribution | |
| C127561-3D | In distribution | |
| C121191-3D | In distribution | |
| RAB1540 | In distribution | |
| C168569-3D | In distribution | |
| C148571-3D-I | In distribution | |
| C161299-3T | In distribution | |
| C149581-3D-I | In distribution | |
| C121191-3T | In distribution | |
| C121210-3D | In distribution | |
| C147561-3T | In distribution | |
| C129581-3T | In distribution | |
| RAB1640 | In distribution | |
| C145541-3D | In distribution | |
| C149581-3T | In distribution | |
| C128571-3D | In distribution | |
| C127561-3T | In distribution | |
| C141191-3D | In distribution | |
| C141210-3T | In distribution | |
| C145541-3T | In distribution | |
| ABS1740 | In distribution | |
| ABS1640 | In distribution | |
| C161189-3D | In distribution | |
| C146551-3T | In distribution | |
| C121210-3T | In distribution | |
| C168569-3T | In distribution | |
| C166549-3D | In distribution | |
| C148571-3T | In distribution | |
| C165539-3D | In distribution | |
| C167559-3T | In distribution | |
| C161299-3D | In distribution | |
| C128571-3T | In distribution | |
| C126551-3D | In distribution | |
| C141191-3T | In distribution | |
| C167559-3D | In distribution | |
| RAB1440 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| IdentiTi | Alphatec Spine, Inc. | 630 |
| Dolomite | Astura Medical | 607 |
| CoRoent | Nuvasive, Inc. | 580 |
| Aeon-C | Diomedical Co., Ltd. | 508 |
| Tomcat™ Cervical Spinal System | Choice Spine, LP | 468 |
| Shoreline ACS | Seaspine Orthopedics Corporation | 428 |
| Zavation | Zavation | 423 |
| Alta™ Stand-Alone Interbody Fusion System | Biomet Spine | 404 |
| Unison™-C Anterior Cervical Fixation System | Pioneer Surgical Technology, Inc. | 334 |
| Chesapeake® Stabilization System | VB Spine LLC | 272 |
| UniSpace® Stand-Alone C Cage | CG MedTech Co., Ltd. | 260 |
| Solitaire-C Cervical Spacer | Biomet Spine | 256 |
Showing 12 of 391. All products under Intervertebral Fusion Device With Integrated Fixation, Cervical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K150053 | 2015-06-24 |
| K142079 | 2014-10-24 |
| K133200 | 2014-05-08 |
| K120819 | 2012-08-31 |
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.