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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, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
510(k) Number K912735
Device Name GENESIS UNICOMPARTMENTAL KNEE SYSTEM
Applicant
SMITH & NEPHEW RICHARDS, INC.
1450 BROOKS RD.
MEMPHIS,  TN  38116
Applicant Contact ROBERT F GAMES
Correspondent
SMITH & NEPHEW RICHARDS, INC.
1450 BROOKS RD.
MEMPHIS,  TN  38116
Correspondent Contact ROBERT F GAMES
Regulation Number888.3520
Classification Product Code
HSX  
Date Received06/20/1991
Decision Date 12/27/1991
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
Recalls CDRH Recalls
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