Genius / Genuin Total Knee System

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

Biorad Medisys PVT LTD

The following data is part of a premarket notification filed by Biorad Medisys Pvt Ltd with the FDA for Genius / Genuin Total Knee System.

Pre-market Notification Details

Device IDK200765
510k NumberK200765
Device Name:Genius / Genuin Total Knee System
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant Biorad Medisys PVT LTD Survey No 48/3 & 48/7, Pashan Sus Road, Sus Village, Taluka Mulshi Pune,  IN 411021
ContactSudhakar Saxena
CorrespondentSudhakar Saxena
Biorad Medisys PVT LTD Survey No 48/3 & 48/7, Pashan Sus Road, Sus Village, Taluka Mulshi Pune,  IN 411021
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-24
Decision Date2021-05-05

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