510(k) K212895 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Paragon 28 External Ring Fixation System
| Applicant | Paragon 28, Inc., Englewood CO, US |
| Decision | Substantially Equivalent, Nov 8, 2021 |
| Received | Sep 10, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212895
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.