PRECICE Intramedullary Limb Lengthening System

PRECICE Intramedullary Limb Lengthening System is an FDA 510(k)-cleared medical device (K150656) manufactured by Ellipse Technologies, Incorporated. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 22, 2015. Regulation: 8.