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 Vy Spine, LLC.
FDA 510(k) Cleared Appliance, Fixation, Spinal Intervertebral Body Devices (Product Code KWQ)
About Product Code KWQ - Regulatory Context
510(k) Submission Activity
664 total 510(k) submissions under product code KWQ since 1979, with 664 receiving FDA clearance (average review time: 110 days).
Submission volume has declined in recent years - 21 submissions in the last 24 months compared to 35 in the prior period.
FDA Review Time
FDA review times for KWQ submissions have been consistent, averaging 100 days recently vs 111 days historically.
KWQ devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →