510(k) K232149 · OUR Sacroiliac Joint Fixation
BowTie SI Joint Fusion System
| Applicant | Sail Fusion, LLC, Del Mar CA, US |
| Decision | Substantially Equivalent, Apr 20, 2024 |
| Received | Jul 19, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232149
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.