510(k) K100373 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
TYCHE PEDICLE SCREW SYSTEM
| Applicant | Kyung Won Medical Co., Ltd., Santa Fe Springs CA, US |
| Decision | Substantially Equivalent, Jun 30, 2010 |
| Received | Feb 12, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100373
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.