510(k) K212028 ยท OLO Orthopedic Stereotaxic Instrument
Dark Star Navigation Instrument System
| Applicant | Republic Spine, LLC, Boca Raton FL, US |
| Decision | Substantially Equivalent, Sep 27, 2021 |
| Received | Jun 29, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212028
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.