510(k) K131810 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM
| Applicant | Osseus Fusion Systems, LLC, Round Rock TX, US |
| Decision | Substantially Equivalent, Aug 8, 2013 |
| Received | Jun 19, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131810
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.