510(k) K243015

Skyway Anterior Cervical Plate System by Kyocera Medical Technologies, Inc. — Product Code KWQ

K243015 is an FDA 510(k) premarket notification submitted by Kyocera Medical Technologies, Inc. for the device "Skyway Anterior Cervical Plate System". The FDA issued a decision of Substantially Equivalent on November 5, 2024. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Kyocera Medical Technologies, Inc. has at least 10 other 510(k) clearances on record.