510(k) K262121 ยท OLO Orthopedic Stereotaxic Instrument
Ion-L Navigated Instruments
| Applicant | SurGenTec, LLC, Boca Raton FL, US |
| Decision | Substantially Equivalent, Jul 24, 2026 |
| Received | Jun 23, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K262121
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.