HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue Cobraid)

HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue Cobraid) is an FDA 510(k)-cleared medical device (K232005) manufactured by Smith & Nephew, 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 August 3, 2023. Regulation: 8.