3DMetal Diaphyseal Femoral Cones

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

Medacta International SA

The following data is part of a premarket notification filed by Medacta International Sa with the FDA for 3dmetal Diaphyseal Femoral Cones.

Pre-market Notification Details

Device IDK200075
510k NumberK200075
Device Name:3DMetal Diaphyseal Femoral Cones
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant Medacta International SA Strada Regina Castel San Pietro,  CH 6874
ContactStefano Baj
CorrespondentChris Lussier
Medacta USA 3973 Delp Street Memphis,  TN  38118
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-14
Decision Date2020-03-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07630971259249 K200075 000
07630971259232 K200075 000
07630971259225 K200075 000
07630971259218 K200075 000

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