510(k) K202192

STRUXXURE®-L and STRUXXURE®-A Plate System by Nexxt Spine, LLC — Product Code KWQ

K202192 is an FDA 510(k) premarket notification submitted by Nexxt Spine, LLC for the device "STRUXXURE®-L and STRUXXURE®-A Plate System". The FDA issued a decision of Substantially Equivalent on September 17, 2020. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Nexxt Spine, LLC has at least 10 other 510(k) clearances on record.