FDA Product Code NKG: Posterior Cervical Screw System
FDA product code NKG covers posterior cervical screw systems.
These implants are used to stabilize the posterior cervical spine through screw-rod or screw-plate constructs anchored to the lateral masses or pedicles of the cervical vertebrae. They are used in the surgical treatment of cervical instability, fractures, deformities, and tumor resection.
NKG devices are Class II medical devices, regulated under 21 CFR 888.3075 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Vy Spine, LLC, Medtronic Sofamor Danek USA, Inc. and CarboFix Orthopedics , Ltd..
List of Posterior Cervical Screw System devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Posterior Cervical Screw System devices (product code NKG). 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 →