FDA AI Clearance Tracker/K253992

Orthopedic · 510(k)

Veritas Reverse Total Shoulder System

Restor3D

Device
Veritas Reverse Total Shoulder System
Company
Restor3D
Submission number
K253992
Pathway
510(k)
Decision date
May 7, 2026
Specialty (lead panel)
Orthopedic
Primary product code
PHX

Source: U.S. FDA AI-Enabled Medical Devices list. The FDA says the list is not comprehensive. Confirm details on the FDA's own record.