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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 K130009
Device Name VARIAX 2 COMPRESSION PLATING SYSTEM
Applicant
Stryker Trauma AG
325 Corporate Drive
Mahwah,  NJ  07430
Applicant Contact ESTELA CELI
Correspondent
Stryker Trauma AG
325 Corporate Drive
Mahwah,  NJ  07430
Correspondent Contact ESTELA CELI
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received01/02/2013
Decision Date 03/22/2013
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
Recalls CDRH Recalls
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