ORTHOPEDIATRICS BONE SCREWS

ORTHOPEDIATRICS BONE SCREWS is an FDA 510(k)-cleared medical device (K082949) manufactured by OrthoPediatrics Corp.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 24, 2008. Regulation: 8.