3D KNEE

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

ENCORE ORTHOPEDICS, INC.

The following data is part of a premarket notification filed by Encore Orthopedics, Inc. with the FDA for 3d Knee.

Pre-market Notification Details

Device IDK020114
510k NumberK020114
Device Name:3D KNEE
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant ENCORE ORTHOPEDICS, INC. 9800 METRIC BLVD. Austin,  TX  78758
ContactJoanna Droege
CorrespondentJoanna Droege
ENCORE ORTHOPEDICS, INC. 9800 METRIC BLVD. Austin,  TX  78758
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-01-11
Decision Date2002-07-12
Summary:summary

NIH GUDID Devices

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Trademark Results [3D KNEE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
3D KNEE
3D KNEE
76225770 not registered Dead/Abandoned
ENCORE ORTHOPEDICS, INC.
2001-03-16

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