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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 K170771
Device Name VariAx 2 Foot System
Stryker GmbH
325 Corporate Drive
Mahwah,  NJ  07430
Applicant Contact Paul Nelson
Stryker GmbH
325 Corporate Drive
Mahwah,  NJ  07430
Correspondent Contact Paul Nelson
Regulation Number888.3030
Classification Product Code
Date Received03/14/2017
Decision Date 05/08/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No