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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 K920426
Device Name PSK FEMORAL AND TIBIAL INSERT COMPONENT
Applicant
ORTHOMET, INC.
6301 CECILIA CIRCLE
MINNEAPOLIS,  MN  55439 -2713
Applicant Contact DENNIS H CRANE
Correspondent
ORTHOMET, INC.
6301 CECILIA CIRCLE
MINNEAPOLIS,  MN  55439 -2713
Correspondent Contact DENNIS H CRANE
Regulation Number888.3560
Classification Product Code
JWH  
Date Received02/03/1992
Decision Date 08/03/1992
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
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