510(k) K141804 ยท NKB Thoracolumbosacral Pedicle Screw System
POLARIS SPINAL SYSTEM - HA COATED
| Applicant | Biomet Spine, LLC, Broomfield CO, US |
| Decision | Substantially Equivalent, Sep 25, 2014 |
| Received | Jul 3, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141804
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.