510(k) K232211 ยท OUR Sacroiliac Joint Fixation
REUNION Sacroiliac Joint Fusion System
| Applicant | Astura Medical, Irving TX, US |
| Decision | Substantially Equivalent, Oct 24, 2023 |
| Received | Jul 26, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232211
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.