510(k) K253718 ยท HRS Plate, Fixation, Bone
enHAnce PEEK Bunion System
| Applicant | Nvision Biomedical Technologies, Inc., San Antonio TX, US |
| Decision | Substantially Equivalent, Apr 1, 2026 |
| Received | Nov 24, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253718
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.