510(k) K243565 · OUR Sacroiliac Joint Fixation
DYNAMIS SI Screw System
| Applicant | Promethean Restorative, LLC, Castle Rock CO, US |
| Decision | Substantially Equivalent, Feb 28, 2025 |
| Received | Nov 18, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243565
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.