510(k) K182919 · OUR Sacroiliac Joint Fixation
SI-Restore® Sacroiliac Joint Fixation System
| Applicant | Biofusion Medical, Austin TX, US |
| Decision | Substantially Equivalent, Jan 25, 2019 |
| Received | Oct 19, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182919
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.