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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 K153721
Device Name iTotal Cruciate Retaining (CR) Knee Replacement System
Applicant
CONFORMIS, INC.
28 Crosby Dr.
Bedford,  MA  01730
Applicant Contact Amita Shah
Correspondent
CONFORMIS, INC.
28 Crosby Dr.
Bedford,  MA  01730
Correspondent Contact Amita Shah
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Codes
OIY   OOG  
Date Received12/28/2015
Decision Date 03/25/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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