THORACOLUMBAR SPINAL ROD SYSTEM (EMPOWER)

THORACOLUMBAR SPINAL ROD SYSTEM (EMPOWER) is an FDA 510(k)-cleared medical device (K983899) manufactured by United States Surgical, A Division of Tyco Healthc. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 21, 1998. Regulation: 8.