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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 K162841
Device Name VariAx Distal Radius Plating System, VariAx 2 System
Applicant
Stryker GmbH
325 Corporate Drive
Mahwah,  NJ  07430
Applicant Contact Irene Bacalocostantis
Correspondent
Stryker GmbH
325 Corporate Drive
Mahwah,  NJ  07430
Correspondent Contact Irene Bacalocostantis
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received10/11/2016
Decision Date 02/21/2017
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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