GRYPHON™ X Anchor; HEALIX TRANSTEND™ Anchor

GRYPHON™ X Anchor; HEALIX TRANSTEND™ Anchor is an FDA 510(k)-cleared medical device (K243790) manufactured by Depuy Mitek. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 4, 2025. Regulation: 8.