ITotal Identity Cruciate Retaining 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 Itotal Identity Cruciate Retaining Knee Replacement System.

Pre-market Notification Details

Device IDK190562
510k NumberK190562
Device Name:ITotal Identity Cruciate Retaining Knee Replacement System
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant Conformis, Inc. 600 Technology Park Drive, 4th Floor Billerica,  MA  01821
ContactPaul Smolenski
CorrespondentPaul Smolenski
Conformis, Inc. 600 Technology Park Drive, 4th Floor Billerica,  MA  01821
Product CodeJWH  
Subsequent Product CodeOIY
Subsequent Product CodeOOG
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-03-05
Decision Date2019-08-08

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