OviTex PRS (Long-Term Resorbable)

OviTex PRS (Long-Term Resorbable) is an FDA 510(k)-cleared medical device (K243595) 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 18, 2024. Regulation: 8.