510(k) K223350 ยท OLO Orthopedic Stereotaxic Instrument
Remi Robotic Navigation System
| Applicant | Fusion Robotics, LLC, Louisville CO, US |
| Decision | Substantially Equivalent, Mar 13, 2023 |
| Received | Nov 2, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223350
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.