LAURE WRIST IMPLANT

LAURE WRIST IMPLANT is an FDA 510(k)-cleared medical device (K803031) manufactured by Laure Prosthetics, 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 June 28, 1982. Regulation: 8.