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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
510(k) Number K201023
Device Name iTotal® Identity Posterior Stabilized Knee Replacement System
Conformis, Inc.
600 Technology Park Drive
Billerica,  MA  01821
Applicant Contact Nancy Giezen
Conformis, Inc.
600 Technology Park Drive
Billerica,  MA  01821
Correspondent Contact Nancy Giezen
Regulation Number888.3560
Classification Product Code
Subsequent Product Codes
Date Received04/20/2020
Decision Date 06/16/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No