ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORS

ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORS is an FDA 510(k)-cleared medical device (K030958) manufactured by Ortho Tec, 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 November 19, 2003. Regulation: 8.