Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS And Identity Imprint Cruciate Retaining (CR) KRS)

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

Pre-market Notification Details

Device IDK212411
510k NumberK212411
Device Name:Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS And Identity Imprint Cruciate Retaining (CR) KRS)
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-03
Decision Date2021-09-23

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