Eminent Spine SI Screw System

Eminent Spine SI Screw System is an FDA 510(k)-cleared medical device (K240505) manufactured by Eminent Spine, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 3, 2024. Regulation: 8.