510(k) K260329 ยท OLO Orthopedic Stereotaxic Instrument
Ion-C Navigation Instruments
| Applicant | SurGenTec, LLC, Boca Raton FL, US |
| Decision | Substantially Equivalent, May 22, 2026 |
| Received | Jan 30, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260329
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.