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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 K061423
Device Name M2A MAGNUM 12/14 TAPER INSERTS AND ONE-PIECE MODULAR HEADS
Original Applicant
BIOMET MANUFACTURING CORP.
56 east bell drive
p.o. box 587
warsaw,  IN  46581 0587
Original Contact becky earl
Regulation Number888.3330
Classification Product Code
KWA  
Date Received05/23/2006
Decision Date 07/27/2006
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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