510(k) K232572 ยท OLO Orthopedic Stereotaxic Instrument
Kalitec Navigated Instrument System
| Applicant | Kalitec Direct, LLC Doing Business AS Kalitec Medical, Orlando FL, US |
| Decision | Substantially Equivalent, Dec 13, 2023 |
| Received | Aug 24, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232572
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.