510(k) K223321

Omnia Medical Coupler-C Anterior Cervical Plate by Omnia Medical, LLC — Product Code KWQ

K223321 is an FDA 510(k) premarket notification submitted by Omnia Medical, LLC for the device "Omnia Medical Coupler-C Anterior Cervical Plate". The FDA issued a decision of Substantially Equivalent on March 13, 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.