510(k) K243888 · JDR Staple, Fixation, Bone
Medline UNITE® REFLEX® Hybrid Nitinol Implant System
| Applicant | Medline Industries, LP, Northfield IL, US |
| Decision | Substantially Equivalent, Apr 11, 2025 |
| Received | Dec 18, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243888
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.