OVINE TISSUE MATRIX(OTM)

OVINE TISSUE MATRIX(OTM) is an FDA 510(k)-cleared medical device (K141053) manufactured by TELA Bio, 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 December 10, 2014. Regulation: 8.