510(k) K023562

MODIFICATION TO CLASSIC GREAT TOE IMPLANT by Nexa Orthopedics, Inc. — Product Code KWH

K023562 is an FDA 510(k) premarket notification submitted by Nexa Orthopedics, Inc. for the device "MODIFICATION TO CLASSIC GREAT TOE IMPLANT". The FDA issued a decision of Substantially Equivalent on November 13, 2002. The device falls under product code KWH (Prosthesis, Toe, Constrained, Polymer), a Class II device regulated under 21 CFR 888.3720. Nexa Orthopedics, Inc. has at least 10 other 510(k) clearances on record.