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FDA 510(k) Applications Submitted by Conformis Inc.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K142404
08/27/2014
iTotal Posterior Stabilized (PS) Knee Replacement System
ConforMIS Inc.
K210191
01/25/2021
Identity Imprint Knee Replacement System
Conformis Inc.
K221059
04/11/2022
Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)
Conformis Inc.
K212411
08/03/2021
Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)
Conformis Inc.
K213389
10/15/2021
Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stabilized (PS) Knee Replacement System
Conformis Inc.
K210252
01/29/2021
iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal Identity Posterior Stabilizing (PS) Knee Replacement System
Conformis Inc.
K230844
03/28/2023
Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert
Conformis Inc.
K221104
04/14/2022
ActeraÖ hip system
Conformis Inc.
K221404
05/16/2022
Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)
Conformis Inc.
K223316
10/28/2022
Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System
Conformis Inc.
K203421
11/20/2020
Triathlon AS-1
Conformis Inc.
K203447
11/23/2020
iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity Posterior Stabilizing (PS) Total Knee Replacement
Conformis Inc.
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