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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 K232595
Device Name Kinos Axiom Total Ankle System
Applicant
Restor3D
4001 E. Nc 54 Hwy., Suite 3160
Durham,  NC  27709
Applicant Contact Brianna Prindle
Correspondent
Restor3D
4001 E. Nc 54 Hwy.
Suite 3160
Durham,  NC  27701
Correspondent Contact Brianna Prindle
Regulation Number888.3110
Classification Product Code
HSN  
Date Received08/25/2023
Decision Date 11/28/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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