PRACTIFIX EXTERNAL FIXATION SYSTEM

PRACTIFIX EXTERNAL FIXATION SYSTEM is an FDA 510(k)-cleared medical device (K960014) manufactured by Orthopaedic Innovations, 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 March 17, 1996. Regulation: 8.