POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA

POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA is an FDA 510(k)-cleared medical device (K143739) manufactured by Smith & Nephew, 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 19, 2015. Regulation: 8.