510(k) K140079 ยท OUR Sacroiliac Joint Fixation
SILEX SACROILIAC JOINT FUSION SYSTEM
| Applicant | X-Spine Systems, Inc., Miamisburg OH, US |
| Decision | Substantially Equivalent, Mar 25, 2014 |
| Received | Jan 13, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140079
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.