K250603
- 510(k) number
- K250603
- Device name
- AxTiHA® Stand-Alone ALIF System
- Applicant
- Innovasis UT · US
- Product code
- OVD — Intervertebral Fusion Device With Integrated Fixatio
- Decision date
- 2025-03-24
- Date received
- 2025-02-28
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K250603.pdf
Official FDA record: K250603
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.