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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 K915132
Device Name MCK MAXIMUM CONGRUENT KNEE) KNEE SYSTEM
Applicant
Biomet, Inc.
P.O. Box 587
Airport Industrial Park
Warsaw,  IN  46581 -0587
Applicant Contact PATRICIA S.BERES
Correspondent
Biomet, Inc.
P.O. Box 587
Airport Industrial Park
Warsaw,  IN  46581 -0587
Correspondent Contact PATRICIA S.BERES
Regulation Number888.3560
Classification Product Code
JWH  
Date Received11/13/1991
Decision Date 02/11/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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