510(k) K021039

BOWTI ANTERIOR BUTTRESS STAPLE SYSTEM by Depuyacromed — Product Code KWQ

K021039 is an FDA 510(k) premarket notification submitted by Depuyacromed for the device "BOWTI ANTERIOR BUTTRESS STAPLE SYSTEM". The FDA issued a decision of Substantially Equivalent on December 11, 2002. 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.