DEPUY LPS PROXIMAL TIBIAL COMPONENT

Prosthesis, Knee, Femorotibial, 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 Lps Proximal Tibial Component.

Pre-market Notification Details

Device IDK062301
510k NumberK062301
Device Name:DEPUY LPS PROXIMAL TIBIAL COMPONENT
ClassificationProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Applicant DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. P.O BOX 988 Warsaw,  IN  46581 -0988
ContactNancy Friddle
CorrespondentNancy Friddle
DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. P.O BOX 988 Warsaw,  IN  46581 -0988
Product CodeKRO  
CFR Regulation Number888.3510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-08-08
Decision Date2006-10-13
Summary:summary

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