OPTIGEN TOTAL KNEE SYSTEM

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

U&I CORP.

The following data is part of a premarket notification filed by U&i Corp. with the FDA for Optigen Total Knee System.

Pre-market Notification Details

Device IDK102367
510k NumberK102367
Device Name:OPTIGEN TOTAL KNEE SYSTEM
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant U&I CORP. 529-1 YONGHYUN-DONG Euijungbu, Kyunggi-do,  KR 480-050
ContactGyeong-je Kwon
CorrespondentGyeong-je Kwon
U&I CORP. 529-1 YONGHYUN-DONG Euijungbu, Kyunggi-do,  KR 480-050
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-08-20
Decision Date2010-12-08
Summary:summary

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