510(k) K212967 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
AxTiHA Stand-Alone ALIF System
| Applicant | Innovasis, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Oct 15, 2021 |
| Received | Sep 16, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K212967
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.