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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 K092178
Device Name AXSOS STRYKER LOCKED PLATING SYSTEM LINE EXTENSION OF CABLE PLUGS
Original Applicant
HOWMEDICA OSTEONICS CORP.
325 corporate drive
mahwah,  NJ  07430
Original Contact melissa a matarese
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received07/21/2009
Decision Date 11/20/2009
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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