AMK TOTAL KNEE SYSTEM W/DU PONT ENHANCED UHMWPE

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

DEPUY, INC.

The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Amk Total Knee System W/du Pont Enhanced Uhmwpe.

Pre-market Notification Details

Device IDK910992
510k NumberK910992
Device Name:AMK TOTAL KNEE SYSTEM W/DU PONT ENHANCED UHMWPE
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant DEPUY, INC. P.O. BOX 988 Warsaw,  IN  46581 -0988
ContactStephen J Peoples
CorrespondentStephen J Peoples
DEPUY, INC. P.O. BOX 988 Warsaw,  IN  46581 -0988
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-03-07
Decision Date1992-08-10

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