510(k) K100765 ยท MNI Orthosis, Spinal Pedicle Fixation
FIXPINE II SYSTEM
| Applicant | Dio Medical Co., Ltd., Santa Fe Springs CA, US |
| Decision | Substantially Equivalent, Jul 19, 2010 |
| Received | Mar 17, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100765
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.