restor3d Reverse Total Shoulder Arthroplasty System

restor3d Reverse Total Shoulder Arthroplasty System is an FDA 510(k)-cleared medical device (K243643) manufactured by Restor3D. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 18, 2025. Regulation: 8.