Salto Talaris Ankle PSI System

Salto Talaris Ankle PSI System is an FDA 510(k)-cleared medical device (K243173) manufactured by 3D Systems, 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 October 24, 2024. Regulation: 8.