510(k) K023770

K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM) by Kinetikos Medical, Inc. — Product Code KWD

K023770 is an FDA 510(k) premarket notification submitted by Kinetikos Medical, Inc. for the device "K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM)". The FDA issued a decision of Substantially Equivalent on December 12, 2002. The device falls under product code KWD (Prosthesis, Toe, Hemi-, Phalangeal), a Class II device regulated under 21 CFR 888.3730. Kinetikos Medical, Inc. has at least 10 other 510(k) clearances on record.