Restoration Modular 115mm Conical Distal Stem

Restoration Modular 115mm Conical Distal Stem is an FDA 510(k)-cleared medical device (K213129) manufactured by Howmedica Osteonics Corp., Dba 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 December 20, 2021. Regulation: 8.