PROFEMUR TL2 Stems

PROFEMUR TL2 Stems is an FDA 510(k)-cleared medical device (K191632) 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 October 6, 2019. Regulation: 8.