510(k) K112748

SLIMPLICITY SOLO ANTERIOR CERVICAL PLATE SYSTEM by Spinal USA, LLC — Product Code KWQ

K112748 is an FDA 510(k) premarket notification submitted by Spinal USA, LLC for the device "SLIMPLICITY SOLO ANTERIOR CERVICAL PLATE SYSTEM". The FDA issued a decision of Substantially Equivalent on July 11, 2012. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Spinal USA, LLC has at least 10 other 510(k) clearances on record.