510(k) K214123 · OUR Sacroiliac Joint Fixation
T-FIX® 3DSI Joint Fusion System
| Applicant | Cutting Edge Spine, LLC, Mineral Springs NC, US |
| Decision | Substantially Equivalent, Jun 24, 2022 |
| Received | Dec 30, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K214123
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.