K251080
- 510(k) number
- K251080
- Device name
- IdentiTi II Cervical Interbody System
- Applicant
- Alphatec Spine, Inc. CA · US
- Product code
- ODP — Intervertebral Fusion Device With Bone Graft, Cervic
- Decision date
- 2025-07-03
- Date received
- 2025-04-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K251080.pdf
Official FDA record: K251080
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.