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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 K190562
Device Name iTotal Identity Cruciate Retaining Knee Replacement System
Applicant
Conformis, Inc.
600 Technology Park Drive, 4th Floor
Billerica,  MA  01821
Applicant Contact Paul Smolenski
Correspondent
Conformis, Inc.
600 Technology Park Drive, 4th Floor
Billerica,  MA  01821
Correspondent Contact Paul Smolenski
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Codes
OIY   OOG  
Date Received03/05/2019
Decision Date 08/08/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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