510(k) K091067 ยท NKB Thoracolumbosacral Pedicle Screw System
5.5 POLARIS SPINAL SYSTEM
| Applicant | Biomet Spine, Parsippany NJ, US |
| Decision | Substantially Equivalent, Jul 14, 2009 |
| Received | Apr 14, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K091067
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.