MOTO Partial Knee System

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

Medacta International SA

The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Moto Partial Knee System.

Pre-market Notification Details

Device IDK183029
510k NumberK183029
Device Name:MOTO Partial Knee System
ClassificationProsthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Applicant Medacta International SA Strada Regina Castel San Pietro,  CH Ch-6874
ContactStefano Baj
CorrespondentChris Lussier
Medacta USA 3973 Delp Street Memphis,  TN  38118
Product CodeHSX  
CFR Regulation Number888.3520 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-11-01
Decision Date2019-01-30
Summary:summary

NIH GUDID Devices

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