510(k) K180337 ยท NKB Thoracolumbosacral Pedicle Screw System
EUROPA Pedicle Screw System
| Applicant | MiRus, LLC, Marietta GA, US |
| Decision | Substantially Equivalent, Mar 14, 2019 |
| Received | Feb 7, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180337
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.