Clearance Summary
IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody System received FDA 510(k) clearance under submission number K251575, sponsored by Alphatec Spine. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2025-09-03.
- Submission: K251575
- Applicant / Sponsor: Alphatec Spine
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3080
- Decision date: 2025-09-03
Classification & Regulation
This clearance is catalogued under FDA product code OVD and 21 CFR 888.3080, within the Orthopedic review panel as a Class II device.