GENESIS POROUS TIBIAL TRAYS & REVISION 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 Porous Tibial Trays & Revision Knee System.

Pre-market Notification Details

Device IDK953274
510k NumberK953274
Device Name:GENESIS POROUS TIBIAL TRAYS & REVISION KNEE SYSTEM
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant SMITH & NEPHEW RICHARDS, INC. 1450 E. BROOKS RD. Memphis,  TN  38116
ContactThomas L Craig
CorrespondentThomas L Craig
SMITH & NEPHEW RICHARDS, INC. 1450 E. BROOKS RD. Memphis,  TN  38116
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-07-14
Decision Date1996-02-05
Summary:summary

NIH GUDID Devices

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