510(k) K182970 · NKB Thoracolumbosacral Pedicle Screw System
EUROPA Pedicle Screw System
| Applicant | MiRus, LLC, Marietta GA, US |
| Decision | Substantially Equivalent, Jan 22, 2019 |
| Received | Oct 26, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182970
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.