GII SPINAL FIXATION SYSTEM

GII SPINAL FIXATION SYSTEM is an FDA 510(k)-cleared medical device (K980852) manufactured by Karen E. Warden, M.E.B.E.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 30, 1998. Regulation: 8.