510(k) K112493 ยท MNI Orthosis, Spinal Pedicle Fixation
PASS LP SPINAL SYSTEM
| Applicant | Medicrea International, Round Rock TX, US |
| Decision | Substantially Equivalent, Nov 21, 2011 |
| Received | Aug 29, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K112493
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.