510(k) K190684 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
LxHA PEEK Lateral IBF System
| Applicant | Innovasis, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Jun 17, 2019 |
| Received | Mar 18, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190684
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.