510(k) K981483

EBI DFS JOINT FIXATOR, MODEL 02800 by Electro-Biology, Inc. — Product Code KTT

K981483 is an FDA 510(k) premarket notification submitted by Electro-Biology, Inc. for the device "EBI DFS JOINT FIXATOR, MODEL 02800". The FDA issued a decision of Substantially Equivalent on July 8, 1998. 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. Electro-Biology, Inc. has at least 10 other 510(k) clearances on record.