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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 K112926
Device Name AXSOS LOCKING PLATE SYSTEM
Applicant
STRYKER CORP.
325 corporate drive
mahwah,  NJ  07430
Contact kelly kucharczyk
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received10/03/2011
Decision Date 12/19/2011
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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