DEPUY UNIVERSAL GRIPTION TF CONES

Prosthesis, Knee, Patellofemorotibial, 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 Universal Gription Tf Cones.

Pre-market Notification Details

Device IDK100391
510k NumberK100391
Device Name:DEPUY UNIVERSAL GRIPTION TF CONES
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
ContactDawn Sinclair, Ma
CorrespondentDawn Sinclair, Ma
DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
Product CodeJWH  
Subsequent Product CodeJDI
Subsequent Product CodeKRO
Subsequent Product CodeKWA
Subsequent Product CodeLPH
Subsequent Product CodeLZO
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-02-16
Decision Date2010-09-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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10603295008415 K100391 000

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