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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 K133256
Device Name ITOTAL CRUCIATE RETAINING, IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEMS, IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM
Applicant
CONFORMIS, INC.
28 Crosby Dr
Bedford,  MA  01730
Applicant Contact ANITA SHAH
Correspondent
CONFORMIS, INC.
28 Crosby Dr
Bedford,  MA  01730
Correspondent Contact ANITA SHAH
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Codes
HSX   NPJ   OOG  
Date Received10/23/2013
Decision Date 01/09/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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