510(k) K253613 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Monkey Rings External Ring Fixation System
| Applicant | Paragon 28, Inc., Englewood CO, US |
| Decision | Substantially Equivalent, Dec 19, 2025 |
| Received | Nov 18, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K253613
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.