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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/polymer, cemented
510(k) Number K050441
Device Name TAPER 2 POROUS FEMORAL STEM
Original Applicant
BIOMET, INC.
56 east bell dr.
warsaw,  IN  46581 0587
Original Contact kacy arnold
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Codes
JDL   KWA   KWB   KWY   KWZ  
LPH   LZO   LZY   MBL   MEH  
Date Received02/22/2005
Decision Date 06/29/2005
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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