510(k) K250074 · KWD Prosthesis, Toe, Hemi-, Phalangeal
HYALEX® MTP Hemiarthroplasty Implant
| Applicant | Hyalex Orthopaedics, Inc., Lexington MA, US |
| Decision | Substantially Equivalent, Apr 3, 2026 |
| Received | Jan 10, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250074
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.