510(k) K152098 ยท MNI Orthosis, Spinal Pedicle Fixation
ODALYS Pedicle Screw System
| Applicant | Kisco International, Saint-Priest, FR |
| Decision | Substantially Equivalent, Sep 17, 2015 |
| Received | Jul 28, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152098
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.