XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm

XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm is an FDA 510(k)-cleared medical device (K260073) manufactured by Biodynamik, 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 February 9, 2026. Regulation: 8.