FDA Product Code KWQ: Appliance, Fixation, Spinal Intervertebral Body
FDA product code KWQ covers spinal intervertebral body fixation appliances.
These devices are implanted between adjacent vertebral bodies to restore disc height, maintain spinal alignment, and facilitate interbody fusion. They include standalone interbody cages and spacers used in anterior, posterior, lateral, and oblique lumbar fusion approaches.
KWQ devices are Class II medical devices, regulated under 21 CFR 888.3060 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Alphatec Spine, Inc., Pioneer Surgical Technology, Inc. and MiRus, LLC.
List of Appliance, Fixation, Spinal Intervertebral Body devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Appliance, Fixation, Spinal Intervertebral Body devices (product code KWQ). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Orthopedic FDA review panel. Browse all Orthopedic devices →