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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 K122033
Device Name ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
Applicant
CONFORMIS, INC.
11 north avenue
burlington,  MA  01803
Contact amita s shah
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
OOG  
Date Received07/16/2012
Decision Date 09/27/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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