510(k) K200868 ยท OUR Sacroiliac Joint Fixation
SI-Restore Sacroiliac Joint Fixation System
| Applicant | Biofusion Medical, Austin TX, US |
| Decision | Substantially Equivalent, Apr 17, 2020 |
| Received | Apr 1, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K200868
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.