510(k) K100409 ยท NKB Thoracolumbosacral Pedicle Screw System
POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTUE ANTERIOR FIXATION SYSTEM
| Applicant | Biomet Spine (Aka Ebi, LLC), Parsippany NJ, US |
| Decision | Substantially Equivalent, Jun 23, 2010 |
| Received | Feb 16, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K100409
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.