OrthoCircle Spine Pedicle Screw System

OrthoCircle Spine Pedicle Screw System is an FDA 510(k)-cleared medical device (K193472) manufactured by Orthocircle 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 February 12, 2020. Regulation: 8.