510(k) K182989 · HWC Screw, Fixation, Bone
AURORA Screw System
| Applicant | MiRus, LLC, Marietta GA, US |
| Decision | Substantially Equivalent, Dec 18, 2018 |
| Received | Oct 29, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182989
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.