510(k) K250603 · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
AxTiHA® Stand-Alone ALIF System
| Applicant | Innovasis, Salt Lake City UT, US |
| Decision | Substantially Equivalent, Mar 24, 2025 |
| Received | Feb 28, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K250603
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.