510(k) K250108 · SBF Orthopedic Augmented Reality
OptiVu Shoulder
| Applicant | Mr Surgical Solutions, LLC, Conshohocken PA, US |
| Decision | Substantially Equivalent, Jul 9, 2025 |
| Received | Jan 16, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250108
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.