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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 K263421
Device Name Veritas Shoulder System
Applicant
restor3d, inc.
4001 Nc Hwy. 54
Suite 3160
Durham,  NC  27709
Applicant Contact Knox Pittman
Correspondent
restor3d, inc.
4001 Nc Hwy. 54
Suite 3160
Durham,  NC  27709
Correspondent Contact Knox Pittman
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Codes
HSD   QHE  
Date Received09/25/2026
Decision Date 10/22/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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