510(k) K240515

uNion® MAX Cervical Plate System by Ulrich Medical USA, Inc. — Product Code KWQ

K240515 is an FDA 510(k) premarket notification submitted by Ulrich Medical USA, Inc. for the device "uNion® MAX Cervical Plate System". The FDA issued a decision of Substantially Equivalent on March 18, 2024. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Ulrich Medical USA, Inc. has at least 10 other 510(k) clearances on record.