510(k) K172323

Omnia Medical VBR by Omnia Medical, LLC — Product Code MQP

K172323 is an FDA 510(k) premarket notification submitted by Omnia Medical, LLC for the device "Omnia Medical VBR". The FDA issued a decision of Substantially Equivalent on October 26, 2017. The device falls under product code MQP (Spinal Vertebral Body Replacement Device), a Class II device regulated under 21 CFR 888.3060. Omnia Medical, LLC has at least 10 other 510(k) clearances on record.