FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT

FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT is an FDA 510(k)-cleared medical device (K981194) manufactured by Nexa Orthopedics, 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 29, 1998. Regulation: 8.