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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 Drive, 4 Floor
Billerica,  MA  01821
Applicant Contact Emmanuel Nyakako
Correspondent
Conformis, Inc.
600 Technology Park Drive, 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
Recalls CDRH Recalls
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