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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 K181091
Device Name AxSOS 3 Ti
Applicant
Stryker GmbH
Bohnackerweg 1
Selzach,  CH 2545
Applicant Contact Saad Attiyah
Correspondent
Stryker GmbH
Bohnackerweg 1
Selzach,  CH 2545
Correspondent Contact Saad Attiyah
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received04/24/2018
Decision Date 10/11/2018
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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