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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 K153379
Device Name AxSOS 3Ti
Applicant
Stryker GmbH
Bohnackerweg 1
Selzach,  CH CH 2545
Applicant Contact Saad Attiyah
Correspondent
Stryker GmbH
Bohnackerweg 1
Selzach,  CH CH 2545
Correspondent Contact Saad Attiyah
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received11/23/2015
Decision Date 05/26/2016
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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