510(k) K212853 ยท OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cervical Stand-Alone System
| Applicant | Eminent Spine, LLC, Plano TX, US |
| Decision | Substantially Equivalent, Nov 5, 2021 |
| Received | Sep 7, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212853
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.