510(k) K211712

3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, CETRA Anterior Cervical Plate System by Orthofix US, LLC — Product Code KWQ

K211712 is an FDA 510(k) premarket notification submitted by Orthofix US, LLC for the device "3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, CETRA Anterior Cervical Plate System". The FDA issued a decision of Substantially Equivalent on Feb 11, 2022. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Orthofix US, LLC has at least 3 other 510(k) clearances on record.