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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name staple, fixation, bone
510(k) Number K122113
Device Name MEMORY METAL STAPLES, EASYCLIP
Original Applicant
STRYKER CORP.
325 corporate drive
mahwah,  NJ  07430
Original Contact estela celi
Regulation Number888.3030
Classification Product Code
JDR  
Date Received07/17/2012
Decision Date 03/12/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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