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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 K203447
Device Name iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity Posterior Stabilizing (PS) Total Knee Replacement
Applicant
Conformis Inc.
600 Technology Park Drive, 4th Floor
Billerica,  MA  01821
Applicant Contact Mary Kruitwagen
Correspondent
Conformis Inc.
600 Technology Park Drive, 4th Floor
Billerica,  MA  01821
Correspondent Contact Mary Kruitwagen
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Codes
OIY   OOG  
Date Received11/23/2020
Decision Date 12/22/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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