Polyscrew Pedicle Screw System

Polyscrew Pedicle Screw System is an FDA 510(k)-cleared medical device (K150647) manufactured by New Era Orthopedics, 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 April 7, 2015. Regulation: 8.