510(k) K262025 · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF System
| Applicant | INNO Holdings Inc. DBA Innovasis, Salt Lake City UT, US |
| Decision | Substantially Equivalent, Sep 11, 2026 |
| Received | Jun 16, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K262025
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.