510(k) K182139 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
AXTi Titanium Stand-Alone ALIF System
| Applicant | Innovasis, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Jun 21, 2019 |
| Received | Aug 7, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182139
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.