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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 K120030
Device Name TAPERLOC COMPLETE SIZE 4MM AND XR 123
Original Applicant
BIOMET MANUFACTURING CORP.
56 east bell drive
p.o. box 587
warsaw,  IN  46581 0587
Original Contact becky earl
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
JDI   KWL   KWY   KWZ   LZO  
MEH   OQG  
Date Received01/04/2012
Decision Date 08/17/2012
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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