Libra Pedicle Screw System

Libra Pedicle Screw System is an FDA 510(k)-cleared medical device (K162750) manufactured by Spinal Balance, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 26, 2016. Regulation: 8.