510(k) K243369

Cervical Plating System by Life Spine, Inc. — Product Code KWQ

K243369 is an FDA 510(k) premarket notification submitted by Life Spine, Inc. for the device "Cervical Plating System". The FDA issued a decision of Substantially Equivalent on December 11, 2024. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Life Spine, Inc. has at least 10 other 510(k) clearances on record.