Stalif C-Ti
STALIF C-Ti is a cervical interbody fusion implant used at one level from C2 to T1 for cervical degenerative disc disease. It is intended for skeletally mature patients after six weeks of…
STALIF C-Ti is a cervical interbody fusion implant used at one level from C2 to T1 for cervical degenerative disc disease. It is intended for skeletally mature patients after six weeks of nonoperative treatment. The cage is used with autograft and the supplied bone screws as a standalone construct.
The cage’s profile follows the vertebral endplate, and its central cavity holds autograft. A PEEK body carries titanium coating on both endplates. Titanium alloy screws provide fixation, while tantalum marker wires make the radiolucent cage’s position visible on X-rays.
Fixation Requirement
The standalone use relies on the bone screws supplied with the system. When used in this configuration, no additional supplemental fixation system is required.
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) | K133200 |
| Record published | 2017-03-20 |
| 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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| C149581-3Tc | In distribution | |
| C129581-3Dc | In distribution | |
| C128571-3Dc | In distribution | |
| C168569-3Dc | In distribution | |
| C147561-3Tc | In distribution | |
| C161299-3Dc | In distribution | |
| C141210-3Dc | In distribution | |
| C125541-3Tc | In distribution | |
| C168569-3Tc | In distribution | |
| C166549-3Dc | In distribution | |
| C128571-3Tc | In distribution | |
| C141210-3Tc | In distribution | |
| C126551-3Dc | In distribution | |
| C129581-3Tc | In distribution | |
| C166549-3Tc | In distribution | |
| C167559-3Tc | In distribution | |
| C145541-3Dc | In distribution | |
| C167559-3Dc | In distribution | |
| C146551-3Tc | In distribution | |
| C165539-3Tc | In distribution | |
| C121191-3Tc | In distribution | |
| C148571-3Dc | In distribution | |
| C147561-3Dc | In distribution | |
| C161299-3Tc | In distribution | |
| C141191-3Tc | In distribution | |
| C126551-3Tc | In distribution | |
| C146551-3Dc | In distribution | |
| C121210-3Dc | In distribution | |
| C121210-3Tc | In distribution | |
| C149581-3Dc | In distribution | |
| C145541-3Tc | In distribution | |
| C165539-3Dc | In distribution | |
| C127561-3Dc | In distribution | |
| C125541-3Dc | In distribution | |
| C148571-3Tc | In distribution | |
| C161189-3Tc | In distribution | |
| C161189-3Dc | In distribution | |
| C169579-3Dc | In distribution | |
| C127561-3Tc | In distribution | |
| C169579-3Tc | In distribution | |
| C141191-3Dc | In distribution | |
| C121191-3Dc | 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.