510(k) K211408

CervAlign® Anterior Cervical Plate System by Pioneer Surgical Technology, Inc. — Product Code KWQ

K211408 is an FDA 510(k) premarket notification submitted by Pioneer Surgical Technology, Inc. for the device "CervAlign® Anterior Cervical Plate System". The FDA issued a decision of Substantially Equivalent on June 23, 2021. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Pioneer Surgical Technology, Inc. has at least 10 other 510(k) clearances on record.