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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 K102580
Device Name VANGUARD REMOVABLE MOLDED POLY TIBIA
Applicant
BIOMET MANUFACTURING CORP.
56 EAST BELL DRIVE
P.O. BOX 587
WARSAW,  IN  46580
Applicant Contact TAMARA J WEST
Correspondent
BIOMET MANUFACTURING CORP.
56 EAST BELL DRIVE
P.O. BOX 587
WARSAW,  IN  46580
Correspondent Contact TAMARA J WEST
Regulation Number888.3560
Classification Product Code
JWH  
Date Received09/08/2010
Decision Date 03/03/2011
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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