510(k) K202309

Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero Facet Screw System, Alpine XC Adjustable Fusion System, Aspen MIS Fusion System, L-Plate MIS Fusion System by Zimmer Biomet Spine, Inc. — Product Code KWQ

K202309 is an FDA 510(k) premarket notification submitted by Zimmer Biomet Spine, Inc. for the device "Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero Facet Screw System, Alpine XC Adjustable Fusion System, Aspen MIS Fusion System, L-Plate MIS Fusion System". The FDA issued a decision of Substantially Equivalent on October 8, 2020. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Zimmer Biomet Spine, Inc. has at least 10 other 510(k) clearances on record.