510(k) K131521

VELOX ANTERIOR CERVICAL PLATE SYSTEM by Spinecraft, LLC — Product Code KWQ

K131521 is an FDA 510(k) premarket notification submitted by Spinecraft, LLC for the device "VELOX ANTERIOR CERVICAL PLATE SYSTEM". The FDA issued a decision of Substantially Equivalent on December 24, 2013. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Spinecraft, LLC has at least 10 other 510(k) clearances on record.