Intelivation Technologies · Class II · Cleared Jan 8, 2026
| K-number | K252711 |
| Device name | Advantage-C Ti3D Cervical Interbody Fusion Device |
| Applicant | Intelivation Technologies |
| Product code | ODP |
| Device class | Class II |
| Decision date | Jan 8, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3080 |
The Advantage-C Ti3D Cervical Interbody Fusion Device is a cervical spine implant made of titanium alloy for treating degenerative disc disease in one vertebral level (C2-T1) in skeletally mature patients. It features a central graft window for autogenous bone graft and is used with supplemental fixation systems.
The device is additively manufactured from medical-grade titanium Ti-6Al-4V ELI (ASTM F3001-14) in various sizes, footprints, heights, and lordotic angles. It introduces no new technological characteristics compared to predicates; material composition and manufacturing methods are consistent with the Ti3Z predicate device, and intended use matches the PEEK predicate.
ASTM F2077 (static and dynamic axial compression, static and dynamic torsion), ASTM F2267 (static subsidence), and static expulsion testing. Testing was conducted in accordance with FDA Guidance and relevant ASTM standards.
View the full FDA submission: accessdata.fda.gov