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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 K080667
Device Name VARIAX DISTAL RADIUS TORX SCREWS
Original Applicant
HOWMEDICA OSTEONICS CORP.
325 corporate drive
mahwah,  NJ  07430
Original Contact danielle hillman
Regulation Number888.3030
Classification Product Code
HRS  
Date Received03/10/2008
Decision Date 03/19/2008
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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