Eminent Spine 3D Titanium Pedicle Screw System

Eminent Spine 3D Titanium Pedicle Screw System is an FDA 510(k)-cleared medical device (K241663) manufactured by Eminent Spine. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 27, 2025. Regulation: 8.