ARTHROSCOPIC SHOULDER LIGAMENT REPAIR KIT

ARTHROSCOPIC SHOULDER LIGAMENT REPAIR KIT is an FDA 510(k)-cleared medical device (K862017) manufactured by Dyonics, 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 December 14, 1986. Regulation: 8.