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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, porous uncemented
510(k) Number K042774
Device Name MALLORY-HEAD MODULAR CALCAR STEMS WITH INTERLOCKING SLOTS
Original Applicant
BIOMET, INC.
56 east bell dr.
warsaw,  IN  46581 0587
Original Contact patricia sandborn beres
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
JDI   JDL   KWA   KWY   KWZ  
LZO  
Date Received10/05/2004
Decision Date 01/21/2005
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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