R&D INNOVATION PEDICLE SCREW SYSTEM

R&D INNOVATION PEDICLE SCREW SYSTEM is an FDA 510(k)-cleared medical device (K120091) manufactured by R&D Innovation, 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 May 17, 2012. Regulation: 8.