BIO-ANCHOR, PRE-LOADED BIOABSORBABLE SUTURE ANCHOR

BIO-ANCHOR, PRE-LOADED BIOABSORBABLE SUTURE ANCHOR is an FDA 510(k)-cleared medical device (K983186) manufactured by Linvatec Corp.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 20, 1998. Regulation: 8.