510(k) K232348 · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
RIGEL 3DR Standalone Anterior Cervical Interbody Fusion System
| Applicant | MiRus, LLC, Marietta GA, US |
| Decision | Substantially Equivalent, Oct 27, 2023 |
| Received | Aug 7, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232348
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.