510(k) K251395 · OUR Sacroiliac Joint Fixation
The Rialto SI Fusion System
| Applicant | Medtronic Sofamor Danek USA, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Jun 26, 2025 |
| Received | May 5, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251395
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.