510(k) K251365 ยท OUR Sacroiliac Joint Fixation
OptumSI Implant System
| Applicant | Si Solutions, LLC, Columbia MO, US |
| Decision | Substantially Equivalent, Nov 20, 2025 |
| Received | May 1, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251365
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.