ITotal Identity Cruciate Retaining (CR) Knee Replacement System, ITotal Identity Posterior Stabilizing (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 Itotal Identity Cruciate Retaining (cr) Knee Replacement System, Itotal Identity Posterior Stabilizing (ps) Knee Replacement System.

Pre-market Notification Details

Device IDK210252
510k NumberK210252
Device Name:ITotal Identity Cruciate Retaining (CR) Knee Replacement System, ITotal Identity Posterior Stabilizing (PS) Knee Replacement System
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant Conformis Inc. 600 Technology Park Drive, 4th Floor Billerica,  MA  01821
ContactMary Kruitwagen
CorrespondentMary Kruitwagen
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-29
Decision Date2021-02-17

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