510(k) K250608 ยท OLO Orthopedic Stereotaxic Instrument
Mako Total Knee Application (3.0); Hybrid Tip Pointer
| Applicant | Mako Surgical Corp., Weston FL, US |
| Decision | Substantially Equivalent, Apr 25, 2025 |
| Received | Feb 28, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250608
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.