510(k) K111448 ยท NKB Thoracolumbosacral Pedicle Screw System
ICON (TM) MODULAR PEDICLE SCREW SYSTEM
| Applicant | Orthofix, Inc., Lewisville TX, US |
| Decision | Substantially Equivalent, Feb 16, 2012 |
| Received | May 24, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111448
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.