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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 K110476
Model 437110S, 437112S, 437114S, 437116S, 437118S, 437120S, 437130S, 437132S, 437134S, 437136S, 437138S, 437140S
Device Name AXSOS (TM) LOCKING PLATE SYSTEM
Original Applicant
STRYKER CORP.
325 corporate drive
mahwah,  NJ  07430
Original Contact estela celi
Regulation Number888.3030
Classification Product Code
HRS  
Date Received02/18/2011
Decision Date 03/18/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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