AVANTA ORTHOPAEDICS TENDON SPACER

AVANTA ORTHOPAEDICS TENDON SPACER is an FDA 510(k)-cleared medical device (K964359) manufactured by Avanta 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 March 24, 1997. Regulation: 8.