510(k) K162236 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Ax Stand-Alone ALIF System
| Applicant | Innovasis, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Apr 20, 2017 |
| Received | Aug 9, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162236
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.