Speed, Speed Shift, Speed Titan, Speed Arc

Speed, Speed Shift, Speed Titan, Speed Arc is an FDA 510(k)-cleared medical device (K142292) manufactured by Biomedical Enterprises, 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 November 16, 2014. Regulation: 8.