510(k) K040197

EAGLE ANTERIOR CERVIAL PLATE SYSTEM by Depuyacromed — Product Code KWQ

K040197 is an FDA 510(k) premarket notification submitted by Depuyacromed for the device "EAGLE ANTERIOR CERVIAL PLATE SYSTEM". The FDA issued a decision of Substantially Equivalent on April 2, 2004. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Depuyacromed has at least 10 other 510(k) clearances on record.