MODIFICATION TO ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR)

MODIFICATION TO ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR) is an FDA 510(k)-cleared medical device (K031219) manufactured by Orthofix, 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 May 27, 2003. Regulation: 8.