GENESIS II TOTAL KNEE SYSTEM

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

SMITH & NEPHEW RICHARDS, INC.

The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Genesis Ii Total Knee System.

Pre-market Notification Details

Device IDK951987
510k NumberK951987
Device Name:GENESIS II TOTAL KNEE SYSTEM
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis,  TN  38116
ContactThomas L Craig
CorrespondentThomas L Craig
SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis,  TN  38116
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-04-27
Decision Date1995-08-22
Summary:summary

NIH GUDID Devices

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