510(k) K112611 ยท MNI Orthosis, Spinal Pedicle Fixation
SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS
| Applicant | Sintea Plastek, LLC, Miami Beach FL, US |
| Decision | Substantially Equivalent, Apr 25, 2012 |
| Received | Sep 7, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K112611
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.