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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
510(K) Number K122160
Device Name VANGUARD XP KNEE SYSTEM
Applicant
BIOMET MANUFACTURING CORP.
56 east bell drive
warsaw,  IN  46582
Contact tracy bickel johnson
Regulation Number888.3565
Classification Product Code
MBH  
Subsequent Product Codes
JWH   MBV   OIY  
Date Received07/20/2012
Decision Date 03/20/2013
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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