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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 K143063
Device Name Stryker SonicPin System, Stryker SonicAnchor System
Applicant
STRYKER TRAUMA GMBH
325 Corporate
Mahwah,  NJ  07430
Applicant Contact Estela Celi
Correspondent
STRYKER TRAUMA GMBH
325 Corporate
Mahwah,  NJ  07430
Correspondent Contact Estela Celi
Regulation Number888.3040
Classification Product Code
HTY  
Subsequent Product Codes
GAT   MAI  
Date Received10/24/2014
Decision Date 01/27/2015
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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