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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 K983004
Device Name CONSENSUS FEMORAL COMPONENT, POROUS, COCR/TI
Applicant
Hayes Medical, Inc.
819 Striker Ave., Suite 10
Sacramento,  CA  95834
Applicant Contact JOHN B STASSI
Correspondent
Hayes Medical, Inc.
819 Striker Ave., Suite 10
Sacramento,  CA  95834
Correspondent Contact JOHN B STASSI
Regulation Number888.3560
Classification Product Code
JWH  
Date Received08/28/1998
Decision Date 11/25/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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