Identity Imprint Cruciate Retaining (CR) Knee Replacement System And Identity Imprint Posterior Stabilized (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 Identity Imprint Cruciate Retaining (cr) Knee Replacement System And Identity Imprint Posterior Stabilized (ps) Knee Replacement System.

Pre-market Notification Details

Device IDK213389
510k NumberK213389
Device Name:Identity Imprint Cruciate Retaining (CR) Knee Replacement System And Identity Imprint Posterior Stabilized (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
ContactKara Johnson
CorrespondentKara Johnson
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 Received2021-10-15
Decision Date2021-11-10

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