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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
Applicant Contact TRACY BICKEL JOHNSON
Correspondent
BIOMET MANUFACTURING CORP.
56 EAST BELL DRIVE
WARSAW,  IN  46582
Correspondent 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 (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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