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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 K193105
Device Name iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal PS 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 Received11/08/2019
Decision Date 03/13/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No