510(k) clearance

Veritas Shoulder System

FDA 510(k) source

510(k) number

K263421

Applicant

restor3d, inc.

Decision date

Oct 22, 2026

Date received

Sep 25, 2026

Decision

Substantially Equivalent

Clearance type

Special

Product code

PHX

Device type

Shoulder Prosthesis, Reverse Configuration

Device class

Class II

Regulation

21 CFR 888.3660

Advisory committee

Orthopedic

Statement or summary

Summary

Third party

N

Location

Durham, NC, US