510(k) K190231 · HWC Screw, Fixation, Bone
InCore® Lapidus Sterile Kits
| Applicant | Nextremity Solutions, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, May 24, 2019 |
| Received | Feb 6, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190231
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.