510(k) K152239

Zero-P Natural Plate System by Synthes (Usa), LLC — Product Code KWQ

K152239 is an FDA 510(k) premarket notification submitted by Synthes (Usa), LLC for the device "Zero-P Natural Plate System". The FDA issued a decision of Substantially Equivalent on December 2, 2015. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Synthes (Usa), LLC has at least 10 other 510(k) clearances on record.