PRECICE Intramedullary Limb Lengthening System

PRECICE Intramedullary Limb Lengthening System is an FDA 510(k)-cleared medical device (K160325) manufactured by Ellipse Technologies, Inc.. 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 3, 2016. Regulation: 8.