510(k) K230424

Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral Lumbar Plate System by Omnia Medical, LLC — Product Code KWQ

K230424 is an FDA 510(k) premarket notification submitted by Omnia Medical, LLC for the device "Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral Lumbar Plate System". The FDA issued a decision of Substantially Equivalent on April 12, 2023. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Omnia Medical, LLC has at least 10 other 510(k) clearances on record.