SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEM

SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEM is an FDA 510(k)-cleared medical device (K984612) manufactured by Synthes Spine. 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 18, 1999. Regulation: 8.