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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 K113550
Device Name VANGUARD COMPLETE KNEE SYSTEM
Applicant
BIOMET MANUFACTURING CORP.
56 EAST BELL DRIVE
P.O. BOX 587
WARSAW,  IN  46581 -0587
Applicant Contact GARY BAKER
Correspondent
BIOMET MANUFACTURING CORP.
56 EAST BELL DRIVE
P.O. BOX 587
WARSAW,  IN  46581 -0587
Correspondent Contact GARY BAKER
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Codes
MBH   OIY  
Date Received12/01/2011
Decision Date 02/29/2012
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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