510(k) K251075 · OUR Sacroiliac Joint Fixation
DYNAMIS Implant System
| Applicant | Promethean Restorative, LLC, Castle Rock CO, US |
| Decision | Substantially Equivalent, Apr 25, 2025 |
| Received | Apr 8, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K251075
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.