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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 K140259
Device Name VARIAX CLAVICLE HOOK PLATE
Applicant
Stryker Trauma AG
325 Corporate Dr.
Mahwah,  NJ  07430
Applicant Contact ELIJAH N WREH
Correspondent
Stryker Trauma AG
325 Corporate Dr.
Mahwah,  NJ  07430
Correspondent Contact ELIJAH N WREH
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received02/03/2014
Decision Date 04/01/2014
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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