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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name appliance, fixation, nail/blade/plate combination, multiple component
510(K) Number K122284
Device Name HOFFMANN 3
Applicant
STRYKER CORP.
325 corporate drive
mahwah,  NJ  07430
Contact estela celi
Regulation Number888.3030
Classification Product Code
KTT  
Date Received07/30/2012
Decision Date 10/24/2012
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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