DEPUY PRESERVATION UNICONDYLAR TIBIA

Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer

DEPUY ORTHOPAEDICS, INC.

The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Preservation Unicondylar Tibia.

Pre-market Notification Details

Device IDK040268
510k NumberK040268
Device Name:DEPUY PRESERVATION UNICONDYLAR TIBIA
ClassificationProsthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
Applicant DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
ContactAbraham Wright
CorrespondentAbraham Wright
DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
Product CodeHRY  
CFR Regulation Number888.3530 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-02-05
Decision Date2004-05-05
Summary:summary

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