PEBA ANCHOR/SUTURE COMBINATION

PEBA ANCHOR/SUTURE COMBINATION is an FDA 510(k)-cleared medical device (K972326) 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 February 5, 1998. Regulation: 8.