SPINE-TECH CERVICAL FIXATION SYSTEM

SPINE-TECH CERVICAL FIXATION SYSTEM is an FDA 510(k)-cleared medical device (K931653) manufactured by Spinal Technologies. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 3, 1994. Regulation: 8.