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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 K190388
Device Name RIVAL View Plating Systems and Reduce Fracture Plating Systems
Applicant
Orthofix Srl
Via Delle Nazioni
9
Bussolengo,  IT 37012
Applicant Contact Gianluca Ricadona
Correspondent
Wagoner Consulting, LLC
P.O. Box 15729
Wilmington,  NC  24408
Correspondent Contact Cheryl Wagoner
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received02/19/2019
Decision Date 06/07/2019
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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