POLYMER THREADED ANCHOR / SUTURE COMBINATION

POLYMER THREADED ANCHOR / SUTURE COMBINATION is an FDA 510(k)-cleared medical device (K982963) manufactured by Orthopaedic Biosystems, Ltd.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 19, 1998. Regulation: 8.