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 Medos International SARL.
FDA 510(k) Cleared Posterior Cervical Screw System Devices (Product Code NKG)
About Product Code NKG - Regulatory Context
510(k) Submission Activity
117 total 510(k) submissions under product code NKG since 2015, with 117 receiving FDA clearance (average review time: 95 days).
Submission volume has declined in recent years - 9 submissions in the last 24 months compared to 16 in the prior period.
FDA Review Time
Recent submissions under NKG have taken an average of 81 days to reach a decision - down from 96 days historically, suggesting improved FDA processing for this classification.
NKG devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →