510(k) K081108 ยท NKB Thoracolumbosacral Pedicle Screw System
MONOPOLY PEDICLE SCREW SYSTEM
| Applicant | Signus Medical, LLC, Washington DC, US |
| Decision | Substantially Equivalent, Jul 14, 2008 |
| Received | Apr 18, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081108
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.