Eminent Spine Scoliosis Deformity Pedicle Screw System

Eminent Spine Scoliosis Deformity Pedicle Screw System is an FDA 510(k)-cleared medical device (K242069) 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 September 2, 2024. Regulation: 8.