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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 K911572
Device Name MG II POROUS COBAL T-CHROME FEMORAL COMPONENT
Applicant
ZIMMER, INC.
P.O. BOX 708
warsaw,  IN  46581 -0708
Applicant Contact carol vierling
Correspondent
ZIMMER, INC.
P.O. BOX 708
warsaw,  IN  46581 -0708
Correspondent Contact carol vierling
Regulation Number888.3560
Classification Product Code
JWH  
Date Received04/08/1991
Decision Date 07/01/1991
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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