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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 K140769
Device Name VARIAX 2 SYSTEM
Applicant
Stryker Trauma AG
325 Corporate Arive
Mahwah,  NJ  07430
Applicant Contact ELIJAH N WREH
Correspondent
Stryker Trauma AG
325 Corporate Arive
Mahwah,  NJ  07430
Correspondent Contact ELIJAH N WREH
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HTN   HWC  
Date Received03/27/2014
Decision Date 04/17/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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