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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 K890132
Device Name POROUS GENESIS PATELLAR AND STEMLESS TIBIAL COMP.
Applicant
Richards Medical Co., Inc.
1450 Brooks Rd.
Memphis,  TN  38116
Applicant Contact ROBERT F GAMES
Correspondent
Richards Medical Co., Inc.
1450 Brooks Rd.
Memphis,  TN  38116
Correspondent Contact ROBERT F GAMES
Regulation Number888.3560
Classification Product Code
JWH  
Date Received01/12/1989
Decision Date 07/19/1989
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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