ECTRA II LIGAMENT RELEASE SYSTEM

ECTRA II LIGAMENT RELEASE SYSTEM is an FDA 510(k)-cleared medical device (K954627) manufactured by Smith & Nephew 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 17, 1995. Regulation: 8.