510(k) K242414 ยท OUR Sacroiliac Joint Fixation
TiLink-P Joint Fusion System
| Applicant | SurGenTec, LLC, Boca Raton FL, US |
| Decision | Substantially Equivalent, Nov 21, 2024 |
| Received | Aug 14, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242414
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.