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 Medtronic Sofamor Danek USA, Inc., Orthofix, Inc. and Medacta International S.A..