Tornier Humeral Reconstruction System (Tornier HRS)

Tornier Humeral Reconstruction System (Tornier HRS) is an FDA 510(k)-cleared medical device (K241609) manufactured by Stryker Corporation (Tornier, 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 September 9, 2024. Regulation: 8.