TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY SYSTEM

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

ALEXANDRIA RESEARCH TECHNOLOGIES, LLC

The following data is part of a premarket notification filed by Alexandria Research Technologies, Llc with the FDA for Tgs Unicompartmental Knee Arthroplasty System.

Pre-market Notification Details

Device IDK090024
510k NumberK090024
Device Name:TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY SYSTEM
ClassificationProsthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Applicant ALEXANDRIA RESEARCH TECHNOLOGIES, LLC 13755 FIRST AVENUE NORTH SUITE 100 Plymouth,  MN  55441
ContactMichael Renner
CorrespondentMichael Renner
ALEXANDRIA RESEARCH TECHNOLOGIES, LLC 13755 FIRST AVENUE NORTH SUITE 100 Plymouth,  MN  55441
Product CodeHSX  
CFR Regulation Number888.3520 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-01-05
Decision Date2009-05-04
Summary:summary

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