Polydioxanone Surgical Scaffold

Polydioxanone Surgical Scaffold is an FDA 510(k)-cleared medical device (K181094) manufactured by Lntegra Lifesciences. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 1, 2018. Regulation: 8.