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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K252959
Device Name WRISTAR MultiAx Distal Radius Kit
Applicant
Intrauma S.P.A
Via A. Meucci 5
Bruino (To),  IT 10090
Applicant Contact Stefano Pullega
Correspondent
MCRA
Via Meucci, 5
Bruino (To),  IT 10090
Correspondent Contact Stefano Pullega
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received09/16/2025
Decision Date 11/12/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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