510(k) K112931 ยท NKB Thoracolumbosacral Pedicle Screw System
LEUCADIA(TM) MIS PEDICLE SCREW SYSTEM
| Applicant | Phygen, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Nov 2, 2011 |
| Received | Oct 3, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K112931
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.