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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Smooth
510(k) Number K170418
Device Name Stryker SonicPin System
Applicant
Stryker Trauma GmbH
Prof-Kuentscher-Str. 1-5
Schoenkirchen,  DE 24232
Applicant Contact Heike Gustke
Correspondent
Stryker Trauma GmbH
Prof-Kuentscher-Str. 1-5
Schoenkirchen,  DE 24232
Correspondent Contact Heike Gustke
Regulation Number888.3040
Classification Product Code
HTY  
Date Received02/13/2017
Decision Date 06/20/2017
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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