510(k) K252088 ยท OLO Orthopedic Stereotaxic Instrument
Firebird SI Navigation System
| Applicant | Orthofix US, LLC, Lewisville TX, US |
| Decision | Substantially Equivalent, Oct 31, 2025 |
| Received | Jul 2, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252088
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.