Balanced Knee System Uni

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

Ortho Development Corporation

The following data is part of a premarket notification filed by Ortho Development Corporation with the FDA for Balanced Knee System Uni.

Pre-market Notification Details

Device IDK211471
510k NumberK211471
Device Name:Balanced Knee System Uni
ClassificationProsthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Applicant Ortho Development Corporation 12187 South Business Park Drive Draper,  UT  84020
ContactDivya Palan
CorrespondentDrew Weaver
Ortho Development Corporation 12187 South Business Park Drive Draper,  UT  84020
Product CodeHSX  
CFR Regulation Number888.3520 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-11
Decision Date2021-12-16

NIH GUDID Devices

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