EXOSHAPE DUO SOFT TISSUE FASTENER

EXOSHAPE DUO SOFT TISSUE FASTENER is an FDA 510(k)-cleared medical device (K132783) manufactured by MedShape, 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 December 8, 2013. Regulation: 8.