Biocore9 Femoral Head Resurfacing Component

Biocore9 Femoral Head Resurfacing Component is an FDA 510(k)-cleared medical device (K201219) manufactured by Biocore9, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 18, 2021. Regulation: 8.