K251575
- 510(k) number
- K251575
- Device name
- IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody System
- Applicant
- Alphatec Spine CA · US
- Product code
- OVD — Intervertebral Fusion Device With Integrated Fixatio
- Decision date
- 2025-09-03
- Date received
- 2025-05-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.9 MB · U.S. public domain
Also available from FDA: K251575.pdf
Official FDA record: K251575
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.