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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ankle Arthroplasty Implantation System
510(k) Number K223326
Device Name Axiom PSR System
Applicant
Restor3D
404 Hunt St.
Suite 500
Durham,  NC  27701
Applicant Contact Brianna Prindle
Correspondent
Restor3D
311 W. Corporation St.
Durham,  NC  27701
Correspondent Contact Brianna Prindle
Regulation Number888.3110
Classification Product Code
OYK  
Date Received10/31/2022
Decision Date 03/30/2023
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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