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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 K153657
Device Name Vanguard XP Knee System
Applicant
BIOMET, INC.
56 EAST BELL DRIVE
WARSAW,  IN  46581
Applicant Contact JULIE GANTENBERG
Correspondent
BIOMET, INC.
56 EAST BELL DRIVE
WARSAW,  IN  46581
Correspondent Contact JULIE GANTENBERG
Regulation Number888.3565
Classification Product Code
MBH  
Subsequent Product Codes
JWH   MBV   OIY  
Date Received12/21/2015
Decision Date 05/10/2016
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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