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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 K142161
Device Name ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM, ITOTAL POSTERIOR STABILIZED (PS) 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 Received08/06/2014
Decision Date 11/14/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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