510(k) K251316 ยท OLO Orthopedic Stereotaxic Instrument
Mazor X System / Mazor X Stealth Edition
| Applicant | Mazor Robotics , Ltd., Caeasarea, IL |
| Decision | Substantially Equivalent, Sep 11, 2025 |
| Received | Apr 29, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251316
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.