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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 K962557
Device Name GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENT
Applicant
SMITH & NEPHEW RICHARDS, INC.
1450 E. BROOKS RD.
MEMPHIS,  TN  38116
Applicant Contact THOMAS L CRAIG
Correspondent
SMITH & NEPHEW RICHARDS, INC.
1450 E. BROOKS RD.
MEMPHIS,  TN  38116
Correspondent Contact THOMAS L CRAIG
Regulation Number888.3560
Classification Product Code
JWH  
Date Received07/01/1996
Decision Date 12/05/1996
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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