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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 K120316
Device Name ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
Applicant
CONFORMIS, INC.
28 Crosby Dr
Bedford,  MA  01730
Applicant Contact AMITA S SHAH
Correspondent
CONFORMIS, INC.
28 Crosby Dr
Bedford,  MA  01730
Correspondent Contact AMITA S SHAH
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
OOG  
Date Received02/01/2012
Decision Date 04/19/2012
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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