DEPUY GCK FEMORAL AND TIBIAL COMPONENTS

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

DEPUY ORTHOPAEDICS, INC.

The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Gck Femoral And Tibial Components.

Pre-market Notification Details

Device IDK070849
510k NumberK070849
Device Name:DEPUY GCK FEMORAL AND TIBIAL COMPONENTS
ClassificationProsthesis, Knee Patellofemorotibial, Partial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
ContactNancy Friddle
CorrespondentNancy Friddle
DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
Product CodeNPJ  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-03-28
Decision Date2007-06-26
Summary:summary

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