Restoration® Modular Hip System

Restoration® Modular Hip System is an FDA 510(k)-cleared medical device (K193233) manufactured by Howmedica Osteonics Corp. (Aka 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 May 26, 2020. Regulation: 8.