510(k) K111957 ยท NKB Thoracolumbosacral Pedicle Screw System
POLARIS SPINAL SYSTEM
| Applicant | Biomet Spine (Ebi, LLC), Parsippany NJ, US |
| Decision | Substantially Equivalent, Aug 19, 2011 |
| Received | Jul 11, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111957
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.