510(k) K243326 ยท OLO Orthopedic Stereotaxic Instrument
Dynamis Robotic Surgical System
| Applicant | LEM Surgical AG, Berne, CH |
| Decision | Substantially Equivalent, Apr 23, 2025 |
| Received | Oct 24, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243326
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.