Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length

Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length is an FDA 510(k)-cleared medical device (K213580) manufactured by Total Joint Othopedics, 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 2, 2021. Regulation: 8.