510(k) K252997 · HRS Plate, Fixation, Bone
HyperFlex® Bunion Correction System
| Applicant | Hyperflex Medical, Port Huron MI, US |
| Decision | Substantially Equivalent, Dec 11, 2025 |
| Received | Sep 18, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252997
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.