510(k) K200696 ยท OUR Sacroiliac Joint Fixation
FIREBIRD SI Fusion System
| Applicant | Orthofix, Inc., Lewisville TX, US |
| Decision | Substantially Equivalent, Apr 2, 2020 |
| Received | Mar 17, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K200696
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 11, 2025 | Orthofix U.S. LLC Brand Name: FIREBIRD" SI Fusion System
Product Name: FIREBIRD" SI Fusion System
Model/Catalog Number: 18-1025SP 11mm X 25mm FIREBIRD SI Screw;
18-1030SP 11mm X 30mm FIREBIRD SI Screw;
18-1035SP 11mm X Open, Classified |
OUR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.