510(k) K190025 · OUR Sacroiliac Joint Fixation
EVOL® -SI Joint Fusion System
| Applicant | Cutting Edge Spine, LLC, Waxhaw NC, US |
| Decision | Substantially Equivalent, Aug 12, 2019 |
| Received | Jan 7, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190025
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.