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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 K240591
Device Name restor3d Kinos Axiom Total Ankle System
Applicant
Restor3D, Inc.
4001 E. Nc 54 Highway, Suite 3160
Durham,  NC  27709
Applicant Contact Anika Moorjani
Correspondent
Restor3D, Inc.
4001 E. Nc 54 Highway, Suite 3160
Durham,  NC  27709
Correspondent Contact Anika Moorjani
Regulation Number888.3110
Classification Product Code
HSN  
Date Received03/01/2024
Decision Date 04/29/2024
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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