510(k) K190069 · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
SixFix Hexapod Fixator and Deformity Analysis and Correction Software (DACS)
| Applicant | Arrowhead De, LLC, Collierville TN, US |
| Decision | Substantially Equivalent, May 14, 2019 |
| Received | Jan 15, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190069
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.