510(k) K190486 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Pitkar External Fixation System
| Applicant | S.H.Pitkar Orthotools Pvt. , Ltd., Pune, IN |
| Decision | Substantially Equivalent, Oct 16, 2019 |
| Received | Feb 28, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190486
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.