FDA Product Code NKB: Thoracolumbosacral Pedicle Screw System
FDA product code NKB covers thoracolumbosacral pedicle screw systems.
These spinal implants are designed to provide immobilization and stabilization of the thoracic, lumbar, and sacral spine. Pedicle screws are inserted into the vertebral pedicles and connected via rods to correct deformity, treat fractures, or facilitate fusion.
NKB devices are Class II medical devices, regulated under 21 CFR 888.3070 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Medtronic Sofamor Danek USA, Inc., Medos International SARL and CarboFix Orthopedics , Ltd..
FDA 510(k) Cleared Thoracolumbosacral Pedicle Screw System Devices (Product Code NKB)
About Product Code NKB - Regulatory Context
510(k) Submission Activity
896 total 510(k) submissions under product code NKB since 2003, with 896 receiving FDA clearance (average review time: 100 days).
Submission volume has declined in recent years - 60 submissions in the last 24 months compared to 84 in the prior period.
FDA Review Time
FDA review times for NKB submissions have been consistent, averaging 101 days recently vs 100 days historically.
NKB devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →