K250074
- 510(k) number
- K250074
- Device name
- HYALEX® MTP Hemiarthroplasty Implant
- Applicant
- Hyalex Orthopaedics, Inc. MA · US
- Product code
- KWD — Prosthesis, Toe, Hemi-, Phalangeal
- Decision date
- 2026-04-03
- Date received
- 2025-01-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K250074.pdf
Official FDA record: K250074
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.