BODYFORM THORACO-LUMBAR FIXATION SYSTEM

BODYFORM THORACO-LUMBAR FIXATION SYSTEM is an FDA 510(k)-cleared medical device (K983622) manufactured by Theken Surgical,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 December 29, 1998. Regulation: 8.