510(k) K230424 · KWQ Appliance, Fixation, Spinal Intervertebral Body
Omnia Medical Coupler-A Anterior Lumbar Plate System; Omnia Medical Coupler-L Lateral Lumbar Plate System
| Applicant | Omnia Medical, LLC, Morgantown WV, US |
| Decision | Substantially Equivalent, Apr 12, 2023 |
| Received | Feb 17, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230424
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.