510(k) K070922

MODIFICATION TO SPINAL USA VBR SYSTEM by Spinal USA — Product Code KWQ

K070922 is an FDA 510(k) premarket notification submitted by Spinal USA for the device "MODIFICATION TO SPINAL USA VBR SYSTEM". The FDA issued a decision of Substantially Equivalent on September 19, 2007. 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.