STRYKER BIOZIP SUTURE ANCHOR SYSTEM

STRYKER BIOZIP SUTURE ANCHOR SYSTEM is an FDA 510(k)-cleared medical device (K041305) manufactured by Stryker Endoscopy. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 13, 2004. Regulation: 8.