S 100 PEDICLE SCREW SYSTEM

S 100 PEDICLE SCREW SYSTEM is an FDA 510(k)-cleared medical device (K111940) manufactured by Renovis Surgical Technologies, 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 14, 2012. Regulation: 8.