BIOLOX delta Option and Extra-long Heads

BIOLOX delta Option and Extra-long Heads is an FDA 510(k)-cleared medical device (K173776) manufactured by Microport Orthopedics, 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 July 5, 2018. Regulation: 8.