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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 K122991
Device Name ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
Applicant
CONFORMIS, INC.
11 NORTH AVENUE
BURLINGTON,  MA  01803
Applicant Contact AMITA SHAH
Correspondent
CONFORMIS, INC.
11 NORTH AVENUE
BURLINGTON,  MA  01803
Correspondent Contact AMITA SHAH
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
OOG  
Date Received09/26/2012
Decision Date 12/20/2012
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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