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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 K180906
Device Name Conformis iTotal Cruciate Retaining (CR) Knee Replacement System
Applicant
Conformis, Inc.
600 Technology Park Dr., 4 Floor
Billerica,  MA  01821
Applicant Contact Emmanuel Nyakako
Correspondent
Conformis, Inc.
600 Technology Park Dr., 4 Floor
Billerica,  MA  01821
Correspondent Contact Emmanuel Nyakako
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Codes
OIY   OOG  
Date Received04/06/2018
Decision Date 05/16/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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