K260624
- 510(k) number
- K260624
- Device name
- Arthrex Radial Head Replacement System
- Applicant
- Arthrex, Inc. FL · US
- Product code
- KWI — Prosthesis, Elbow, Hemi-, Radial, Polymer
- Decision date
- 2026-07-30
- Date received
- 2026-02-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K260624.pdf
Official FDA record: K260624
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.