NEW ERA ORTHOPAEDICS POLYSCREW PEDICLE SCREW SYSTEM

NEW ERA ORTHOPAEDICS POLYSCREW PEDICLE SCREW SYSTEM is an FDA 510(k)-cleared medical device (K141253) manufactured by New Era Orthopaedics, 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 January 8, 2015. Regulation: 8.