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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prosthesis, hip, semi-constrained (metal uncemented acetabular component)
510(k) Number K050251
Device Name BALANCE HIP SYSTEM
Original Applicant
BIOMET, INC.
56 east bell dr.
warsaw,  IN  46581 0587
Original Contact gary baker
Regulation Number888.3330
Classification Product Code
KWA  
Subsequent Product Codes
JDI   JDL   KWY   KWZ   LPH  
LZO   LZY   MEH  
Date Received02/03/2005
Decision Date 05/27/2005
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
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