SYNTHES SPINE PEDIATRIC ROD SYSTEM

SYNTHES SPINE PEDIATRIC ROD SYSTEM is an FDA 510(k)-cleared medical device (K980761) 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 August 3, 1998. Regulation: 8.