OviTex PRS (Long Term Resorbable)

OviTex PRS (Long Term Resorbable) is an FDA 510(k)-cleared medical device (K214070) manufactured by Tela Bio. 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 March 20, 2023. Regulation: 8.