510(k) K253488 · OUR Sacroiliac Joint Fixation
iFuse INTRA Ti Implant System
| Applicant | SI-BONE, Inc., Santa Clara CA, US |
| Decision | Substantially Equivalent, Feb 11, 2026 |
| Received | Oct 24, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253488
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.