510(k) K140678 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
COSMOLOCK PEDICLE SCREW SYSTEM
| Applicant | Kalitec Direct, LLC, Round Rock TX, US |
| Decision | Substantially Equivalent, Jun 19, 2014 |
| Received | Mar 18, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140678
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.