CROSSOVER CROSS CONNECTOR (ISOLA SPINAL SYSTEM)

CROSSOVER CROSS CONNECTOR (ISOLA SPINAL SYSTEM) is an FDA 510(k)-cleared medical device (K021879) manufactured by Depuyacromed. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 25, 2002. Regulation: 8.