510(k) K253611 ยท OUR Sacroiliac Joint Fixation
Falco Fusion System
| Applicant | Mcnicoll Surgical, Inc., Quebec City, CA |
| Decision | Substantially Equivalent, Jan 29, 2026 |
| Received | Nov 18, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253611
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.