Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws

Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws is an FDA 510(k)-cleared medical device (K161569) manufactured by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 13, 2016. Regulation: 8.