510(k) K091044

SPINAL USA ANTERIOR LUMBAR PLATE SYSTEM by Spinal USA — Product Code KWQ

K091044 is an FDA 510(k) premarket notification submitted by Spinal USA for the device "SPINAL USA ANTERIOR LUMBAR PLATE SYSTEM". The FDA issued a decision of Substantially Equivalent on July 9, 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.