SGARLATO FLEXIBLE HINGE TOE IMPLANT

SGARLATO FLEXIBLE HINGE TOE IMPLANT is an FDA 510(k)-cleared medical device (K905795) manufactured by Sgarlato Laboratories, 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 May 28, 1991. Regulation: 8.