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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 K210809
Device Name iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)
Applicant
Conformis, Inc.
600 Technology Park Drive, Fourth Floor
Billerica,  MA  01821
Applicant Contact Mary Kruitwagen
Correspondent
Conformis, Inc.
600 Technology Park Drive, Fourth Floor
Billerica,  MA  01821
Correspondent Contact Mary Kruitwagen
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Codes
OIY   OOG  
Date Received03/17/2021
Decision Date 05/12/2021
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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