510(k) K193524 · OUR Sacroiliac Joint Fixation
SI-BONE iFuse Implant System®
| Applicant | SI-BONE, Inc., Santa Clara CA, US |
| Decision | Substantially Equivalent, Mar 31, 2020 |
| Received | Dec 19, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193524
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.