510(k) K080099 ยท MNI Orthosis, Spinal Pedicle Fixation
PASS SPINAL SYSTEM
| Applicant | Medicrea Technologies, Round Rock TX, US |
| Decision | Substantially Equivalent, Apr 9, 2008 |
| Received | Jan 14, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K080099
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.