ADVANCE UNICONDYLAR KNEE SYSTEM

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

WRIGHT MEDICAL TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Advance Unicondylar Knee System.

Pre-market Notification Details

Device IDK014171
510k NumberK014171
Device Name:ADVANCE UNICONDYLAR KNEE SYSTEM
ClassificationProsthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
Applicant WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington,  TN  38002
ContactEhab M Esmail
CorrespondentEhab M Esmail
WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington,  TN  38002
Product CodeHRY  
CFR Regulation Number888.3530 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-12-20
Decision Date2002-03-15
Summary:summary

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