510(k) K223070 ยท OLO Orthopedic Stereotaxic Instrument
Remi Robotic Navigation System
| Applicant | Fusion Robotics, LLC, Louisville CO, US |
| Decision | Substantially Equivalent, Oct 28, 2022 |
| Received | Sep 30, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K223070
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.