POLARSTEM Calcar Reamer Guide

POLARSTEM Calcar Reamer Guide is an FDA 510(k)-cleared medical device (K211548) 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 July 18, 2021. Regulation: 8.