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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 K122770
Model 110003660-99, 10003797-831
Device Name BIOMET RECONSTRUCTIVE WEDGES MODEL 110003660-99, 110003797-831
Original Applicant
56 bell drive
warsaw,  IN  46580
Original Contact patricia sandborn beres
Regulation Number888.3030
Classification Product Code
Subsequent Product Code
Date Received09/10/2012
Decision Date 03/28/2013
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