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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 K033489
Device Name AGC TOTAL KNEE SYSTEM KNEE, ASCENT TOTAL KNEE SYSTEM, MAXIM COMPLETE KNEE SYSTEM, MAXIM ACCEL KNEE SYSTEM ALSO KNOWN
Applicant
BIOMET, INC.
56 EAST BELL DR.
P.O. BOX 587
WARSAW,  IN  46581 -0587
Applicant Contact PATRICIA SANDBORN BERES
Correspondent
BIOMET, INC.
56 EAST BELL DR.
P.O. BOX 587
WARSAW,  IN  46581 -0587
Correspondent Contact PATRICIA SANDBORN BERES
Regulation Number888.3565
Classification Product Code
MBH  
Date Received11/04/2003
Decision Date 06/02/2004
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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