LUQUE III SPINAL SYSTEM AND LUQUE MINI-SET

LUQUE III SPINAL SYSTEM AND LUQUE MINI-SET is an FDA 510(k)-cleared medical device (K890192) manufactured by Danek Medical, 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 January 3, 1990. Regulation: 8.