SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEE

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

SMITH & NEPHEW, INC.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew, Inc. High Performance Knee.

Pre-market Notification Details

Device IDK042515
510k NumberK042515
Device Name:SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEE
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis,  TN  38116
ContactJanet Johnson Akil
CorrespondentJanet Johnson Akil
SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis,  TN  38116
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-09-16
Decision Date2005-03-14
Summary:summary

NIH GUDID Devices

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