510(k) K192578 ยท HWC Screw, Fixation, Bone
InCore TMT System
| Applicant | Nextremity Solutions, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Dec 31, 2019 |
| Received | Sep 19, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192578
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.