510(k) K033763

MODIFICATION TO SLIM GLIDING NAIL SYSTEM by Plus Orthopedics — Product Code KTT

K033763 is an FDA 510(k) premarket notification submitted by Plus Orthopedics for the device "MODIFICATION TO SLIM GLIDING NAIL SYSTEM". The FDA issued a decision of Substantially Equivalent on December 18, 2003. The device falls under product code KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component), a Class II device regulated under 21 CFR 888.3030. Plus Orthopedics has at least 10 other 510(k) clearances on record.