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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 K063875
Device Name STRYKER FOOT PLATING SYSTEM
Original Applicant
HOWMEDICA OSTEONICS CORP.
325 corporate drive
mahwah,  NJ  07430
Original Contact vivian kelly
Regulation Number888.3030
Classification Product Code
HRS  
Date Received12/29/2006
Decision Date 03/15/2007
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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