510(k) K260222 ยท OLO Orthopedic Stereotaxic Instrument
Mako Total Knee Application
| Applicant | Mako Surgical Corp., Weston FL, US |
| Decision | Substantially Equivalent, Feb 25, 2026 |
| Received | Jan 26, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K260222
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.