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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name screw, fixation, bone
510(k) Number K071092
Device Name ASNIS MICRO CANNULATED SCREW
Original Applicant
HOWMEDICA OSTEONICS CORP.
325 corporate drive
mahwah,  NJ  07430
Original Contact vivian kelly
Regulation Number888.3040
Classification Product Code
HWC  
Date Received04/18/2007
Decision Date 05/11/2007
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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