GMK FULL PE TIBIAL COMPONENTS

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

MEDACTA INTERNATIONAL

The following data is part of a premarket notification filed by Medacta International with the FDA for Gmk Full Pe Tibial Components.

Pre-market Notification Details

Device IDK131310
510k NumberK131310
Device Name:GMK FULL PE TIBIAL COMPONENTS
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant MEDACTA INTERNATIONAL 4725 Calle Quetzal, Unit B Camarillo,  CA  93012
ContactAdam Gross
CorrespondentAdam Gross
MEDACTA INTERNATIONAL 4725 Calle Quetzal, Unit B Camarillo,  CA  93012
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-05-07
Decision Date2013-08-22
Summary:summary

NIH GUDID Devices

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