510(k) K905795

SGARLATO FLEXIBLE HINGE TOE IMPLANT by Sgarlato Laboratories, Inc. — Product Code KWH

K905795 is an FDA 510(k) premarket notification submitted by Sgarlato Laboratories, Inc. for the device "SGARLATO FLEXIBLE HINGE TOE IMPLANT". The FDA issued a decision of Substantially Equivalent on May 29, 1991. The device falls under product code KWH (Prosthesis, Toe, Constrained, Polymer), a Class II device regulated under 21 CFR 888.3720. Sgarlato Laboratories, Inc. has at least 7 other 510(k) clearances on record.