Synthecure Synthetic Calcium Sulfate

Synthecure Synthetic Calcium Sulfate is an FDA 510(k)-cleared medical device (K250141) manufactured by Austin Medical Ventures, 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 15, 2025. Regulation: 8.