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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shoulder Prosthesis, Reverse Configuration
510(k) Number K253992
Device Name Veritas Reverse Total Shoulder System
Applicant
Restor3D
4001 Nc-54 Hwy.
Suite 2160
Durham,  NC  27709
Applicant Contact Brianna Prindle
Correspondent
Restor3D
4001 Nc-54 Hwy.
Suite 2160
Durham,  NC  27709
Correspondent Contact Brianna Prindle
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Code
QHE  
Date Received12/12/2025
Decision Date 05/07/2026
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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