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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 K142404
Device Name iTotal Posterior Stabilized (PS) Knee Replacement System
ConforMIS Inc.
28 Crosby DR.
Bedford,  MA  01730
Applicant Contact Amita Shah
ConforMIS Inc.
28 Crosby DR.
Bedford,  MA  01730
Correspondent Contact Amita Shah
Regulation Number888.3560
Classification Product Code
Date Received08/27/2014
Decision Date 12/11/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls