SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction

SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction is an FDA 510(k)-cleared medical device (K162965) manufactured by Tei Biosciences, Inc.. 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 February 15, 2017. Regulation: 8.