Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem

Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem is an FDA 510(k)-cleared medical device (K220731) manufactured by Stryker. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 10, 2022. Regulation: 8.