510(k) K251862 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
External Fixation Bone Distractor
| Applicant | Paragon 28, Inc., Englewood CO, US |
| Decision | Substantially Equivalent, Aug 11, 2025 |
| Received | Jun 17, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251862
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.