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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 K230846
Device Name iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System
Applicant
Conformis, Inc.
600 Technology Park Dr.
Billerica,  MA  01830
Applicant Contact Nancy Giezen
Correspondent
Conformis, Inc.
600 Technology Park Dr.
Billerica,  MA  01830
Correspondent Contact Nancy Giezen
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Codes
OIY   OOG  
Date Received03/28/2023
Decision Date 07/17/2023
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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