PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar

PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar is an FDA 510(k)-cleared medical device (K200007) 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 April 24, 2020. Regulation: 8.