510(k) K110046 ยท NKB Thoracolumbosacral Pedicle Screw System
ATHENA PEDICLE SCREW SYSTEM
| Applicant | Royal Oak Medical Devices, Bloomfield Hills MI, US |
| Decision | Substantially Equivalent, Dec 7, 2011 |
| Received | Jan 6, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110046
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.