INSTAFIX SHAPE MEMORY FIXATION SYSTEM

INSTAFIX SHAPE MEMORY FIXATION SYSTEM is an FDA 510(k)-cleared medical device (K141550) manufactured by Ot Medical. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 10, 2014. Regulation: 8.