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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 K833921
Device Name AGC TOTAL KNEE PROSTHESIS
Applicant
BIOMET, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
BIOMET, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number888.3560
Classification Product Code
JWH  
Date Received11/14/1983
Decision Date 01/31/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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