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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, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
510(k) Number K143192
Device Name Vanguard 360 Revision Knee System
Applicant
Biomet, Inc.
56 East Bell Drive
Warsaw,  IN  46581
Applicant Contact Jason Heckaman
Correspondent
Biomet, Inc.
56 East Bell Drive
Warsaw,  IN  46581
Correspondent Contact Jason Heckaman
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
MBV  
Date Received11/06/2014
Decision Date 02/12/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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