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 Medos International SARL, CarboFix Orthopedics , Ltd. and Medtronic Sofamor Danek USA, Inc..
List of Thoracolumbosacral Pedicle Screw System devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Thoracolumbosacral Pedicle Screw System devices (product code NKB). 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 →