510(k) K111370 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
ODALYS PEDICLE SCREW SYSTEM
| Applicant | Kalitec Direct, LLC, Round Rock TX, US |
| Decision | Substantially Equivalent, Sep 21, 2011 |
| Received | May 16, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111370
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.