510(k) K252058 ยท OLO Orthopedic Stereotaxic Instrument
ROSA Knee System with UltraSound Imaging Platform (USIP)
| Applicant | Balmoral Medical, LLC, Rosemont IL, US |
| Decision | Substantially Equivalent, Feb 6, 2026 |
| Received | Jul 1, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252058
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.