510(k) K201587

icotec Anterior Cervical Plate System by Icotec AG — Product Code KWQ

K201587 is an FDA 510(k) premarket notification submitted by Icotec AG for the device "icotec Anterior Cervical Plate System". The FDA issued a decision of Substantially Equivalent on October 15, 2020. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Icotec AG has at least 10 other 510(k) clearances on record.