IUni Unicondylar Knee Replacement System, IDuo Bicompartmental Knee Repair System, ITotal CR Knee Replacement System, ITotal PS Knee Replacement System

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

Conformis, Inc.

The following data is part of a premarket notification filed by Conformis, Inc. with the FDA for Iuni Unicondylar Knee Replacement System, Iduo Bicompartmental Knee Repair System, Itotal Cr Knee Replacement System, Itotal Ps Knee Replacement System.

Pre-market Notification Details

Device IDK193105
510k NumberK193105
Device Name:IUni Unicondylar Knee Replacement System, IDuo Bicompartmental Knee Repair System, ITotal CR Knee Replacement System, ITotal PS Knee Replacement System
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant Conformis, Inc. 600 Technology Park Drive Billerica,  MA  01821
ContactNancy Giezen
CorrespondentNancy Giezen
Conformis, Inc. 600 Technology Park Drive Billerica,  MA  01821
Product CodeJWH  
Subsequent Product CodeHSX
Subsequent Product CodeNPJ
Subsequent Product CodeOIY
Subsequent Product CodeOOG
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-08
Decision Date2020-03-13

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