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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 K110201
Device Name EXPLOR RADIAL HEAD PLATING SYSTEM
Original Applicant
BIOMET, INC.
56 east bell dr.
box 587
warsaw,  IN  46581 -0587
Original Contact patricia s beres
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received01/24/2011
Decision Date 07/21/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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