510(k) K090203 ยท NKB Thoracolumbosacral Pedicle Screw System
5.5 HELICAL FLANGE SPINAL SYSTEM, POLARIS COMPONENTS
| Applicant | Ebi, L.P., Parsippany NJ, US |
| Decision | Substantially Equivalent, Jul 30, 2009 |
| Received | Jan 27, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K090203
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.