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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
Applicant
BIOMET, INC.
56 EAST BELL DR.
BOX 587
WARSAW,  IN  46581 -0587
Applicant Contact KACY ARNOLD
Correspondent
BIOMET, INC.
56 EAST BELL DR.
BOX 587
WARSAW,  IN  46581 -0587
Correspondent 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 (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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