510(k) K023360

LEFORTE SYSTEM BONE PLATE by Jeil Medical Corporation — Product Code KTW

K023360 is an FDA 510(k) premarket notification submitted by Jeil Medical Corporation for the device "LEFORTE SYSTEM BONE PLATE". The FDA issued a decision of Substantially Equivalent on October 25, 2002. The device falls under product code KTW (Appliance, Fixation, Nail/Blade/Plate Combination, Single Component), a Class II device regulated under 21 CFR 888.3030. Jeil Medical Corporation has at least 10 other 510(k) clearances on record.