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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, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
510(k) Number K132640
Device Name IUNI UNICONDYLAR 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 Number888.3520
Classification Product Code
HSX  
Subsequent Product Code
OOG  
Date Received08/23/2013
Decision Date 12/05/2013
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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