510(k) K183342 ยท OUR Sacroiliac Joint Fixation
SambaScrew 3D SI Fusion System
| Applicant | Orthofix, Inc., Lewisville TX, US |
| Decision | Substantially Equivalent, Apr 30, 2019 |
| Received | Dec 3, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183342
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.