510(k) K201029

Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System by Spinal Elements, Inc. — Product Code KWQ

K201029 is an FDA 510(k) premarket notification submitted by Spinal Elements, Inc. for the device "Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System". The FDA issued a decision of Substantially Equivalent on June 17, 2020. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Spinal Elements, Inc. has at least 10 other 510(k) clearances on record.