Flexible Suturing System with Anchors (FSSA)

Flexible Suturing System with Anchors (FSSA) is an FDA 510(k)-cleared medical device (K222589) manufactured by Integrity Orthopaedics, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 25, 2023. Regulation: 8.