510(k) K160291 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Optimus ALIF System
| Applicant | Amendia, Inc., Marietta GA, US |
| Decision | Substantially Equivalent, Feb 18, 2016 |
| Received | Feb 3, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K160291
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.