510(k) K140417

DIVERGENCE MINI-PLATE ANTERIOR CERVICAL FUSION SYSTEM by Medtronic Sofamor Danek, Inc. — Product Code KWQ

K140417 is an FDA 510(k) premarket notification submitted by Medtronic Sofamor Danek, Inc. for the device "DIVERGENCE MINI-PLATE ANTERIOR CERVICAL FUSION SYSTEM". The FDA issued a decision of Substantially Equivalent on July 9, 2014. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Medtronic Sofamor Danek, Inc. has at least 10 other 510(k) clearances on record.