510(k) K253094 ยท OUR Sacroiliac Joint Fixation
iFuse Bedrock Granite Implant System
| Applicant | SI-BONE, Inc., Santa Clara CA, US |
| Decision | Substantially Equivalent, Oct 9, 2025 |
| Received | Sep 23, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K253094
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.