510(k) K183659 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Omnia Medical Rotary PLIF System
| Applicant | Omnia Medical, LLC, Morgantown, WV, US |
| Decision | Substantially Equivalent, Feb 6, 2019 |
| Received | Dec 27, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183659
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.