510(k) K100297 ยท MNI Orthosis, Spinal Pedicle Fixation
PASS LP SPINAL SYSTEM
| Applicant | Medicrea Technologies, Round Rock TX, US |
| Decision | Substantially Equivalent, Mar 4, 2010 |
| Received | Feb 2, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100297
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.