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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 K062995
Device Name M2A-MAGNUM TRI-SPIKE ACETABULAR COMPONENT
Original Applicant
BIOMET MANUFACTURING CORP.
po box 587
warsaw,  IN  46581 0587
Original Contact patricia s beres
Regulation Number888.3330
Classification Product Code
KWA  
Date Received10/02/2006
Decision Date 10/31/2006
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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