AGC TOTAL KNEE SYSTEM KNEE, ASCENT TOTAL KNEE SYSTEM, MAXIM COMPLETE KNEE SYSTEM, MAXIM ACCEL KNEE SYSTEM ALSO KNOWN

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

Correspodent Contact patricia sandborn beres
Regulation Number 888.3565
Classification Product Code
MBH  
Date Received 11/04/2003
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