TITLE 2 POLYAXIAL SPINAL SYSTEM

TITLE 2 POLYAXIAL SPINAL SYSTEM is an FDA 510(k)-cleared medical device (K133086) manufactured by Zimmer Spine, 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 November 26, 2013. Regulation: 8.