510(k) K253444 · OLO Orthopedic Stereotaxic Instrument
EUROPA Posterior Cervical Fusion Navigated Instruments
| Applicant | MiRus, LLC, Marietta GA, US |
| Decision | Substantially Equivalent, Mar 18, 2026 |
| Received | Oct 2, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253444
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.