Chiral Surgical Pedicle Screw System

Chiral Surgical Pedicle Screw System is an FDA 510(k)-cleared medical device (K181995) manufactured by Chiral Surgical. 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 19, 2018. Regulation: 8.