510(k) K213590 ยท OUR Sacroiliac Joint Fixation
Blue Topaz Sacroiliac Screw System
| Applicant | Osseus Fusion Systems, LLC, Dallas TX, US |
| Decision | Substantially Equivalent, Mar 1, 2022 |
| Received | Nov 12, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213590
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.