510(k) K212937

Dakota ALIF Plate System by Precision Spine, Inc. — Product Code KWQ

K212937 is an FDA 510(k) premarket notification submitted by Precision Spine, Inc. for the device "Dakota ALIF Plate System". The FDA issued a decision of Substantially Equivalent on November 4, 2021. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Precision Spine, Inc. has at least 10 other 510(k) clearances on record.