K252959
- 510(k) number
- K252959
- Device name
- WRISTAR MultiAx Distal Radius Kit
- Applicant
- Intrauma S.P.A IT
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2025-11-12
- Date received
- 2025-09-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K252959.pdf
Official FDA record: K252959
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.