FREEDOM INGUINAL HERNIA IMPLANT

FREEDOM INGUINAL HERNIA IMPLANT is an FDA 510(k)-cleared medical device (K113552) manufactured by Insightra Medical. 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 22, 2012. Regulation: 8.