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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 K091955
Device Name STRYKER SONICPIN SYSTEM
Applicant
Howmedica Osteonics Corp.
325 Corporate Dr.
Mahwah,  NJ  07430
Applicant Contact AVITAL MERL-MARGULIES
Correspondent
Howmedica Osteonics Corp.
325 Corporate Dr.
Mahwah,  NJ  07430
Correspondent Contact AVITAL MERL-MARGULIES
Regulation Number888.3040
Classification Product Code
HTY  
Date Received07/01/2009
Decision Date 04/02/2010
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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