OXINIUM DH Fermoral Heads

OXINIUM DH Fermoral Heads is an FDA 510(k)-cleared medical device (K161233) 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 December 13, 2016. Regulation: 8.