OrthoPediatrics Titanium PediPlates® System

OrthoPediatrics Titanium PediPlates® System is an FDA 510(k)-cleared medical device (K171173) 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 August 23, 2017. Regulation: 8.