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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
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