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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
510(k) Number K242868
Device Name Kinos Total Ankle System
Applicant
Restor3d
4001 Nc 54 Highway
Suite 3160
Durham,  NC  27709
Applicant Contact Brianna Prindle
Correspondent
Restor3d
4001 Nc 54 Highway
Suite 3160
Durham,  NC  27709
Correspondent Contact Knox Pittman
Regulation Number888.3110
Classification Product Code
HSN  
Date Received09/20/2024
Decision Date 10/18/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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