510(k) K250247 ยท OUR Sacroiliac Joint Fixation
panaSIa SI Fusion System
| Applicant | Wenzel Spine, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Jul 9, 2025 |
| Received | Jan 27, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250247
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.