510(k) K092659

SPINAL USA RCS ANTERIOR LUMBAR BUTRESS PLATE SYSTEM, MODEL 22-1001-25 by Spinal USA — Product Code KWQ

K092659 is an FDA 510(k) premarket notification submitted by Spinal USA for the device "SPINAL USA RCS ANTERIOR LUMBAR BUTRESS PLATE SYSTEM, MODEL 22-1001-25". The FDA issued a decision of Substantially Equivalent on November 17, 2009. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Spinal USA has at least 10 other 510(k) clearances on record.