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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, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
510(k) Number K243768
Device Name iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System
Applicant
Restor3D, Inc.
4001 Nc 54, Suite 3160
Durham,  NC  27709
Applicant Contact Brianna Prindle
Correspondent
Restor3D, Inc.
4001 Nc 54, Suite 3160
Durham,  NC  27709
Correspondent Contact Brianna Prindle
Regulation Number888.3565
Classification Product Code
MBH  
Subsequent Product Codes
JWH   OIY   OOG  
Date Received12/06/2024
Decision Date 03/27/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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