CalcShift™ Displacement Calcaneal Osteotomy System

CalcShift™ Displacement Calcaneal Osteotomy System is an FDA 510(k)-cleared medical device (K212979) manufactured by Nextremity Solutions, 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 May 19, 2022. Regulation: 8.