PROFEMUR® GLADIATOR® Cemented Classic Stem

PROFEMUR® GLADIATOR® Cemented Classic Stem is an FDA 510(k)-cleared medical device (K201519) 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 December 9, 2020. Regulation: 8.