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 Medacta International S.A., Medos International SARL and Medtronic Sofamor Danek USA, Inc..
118
Total
118
Cleared
96d
Avg days
2015
Since
Declining activity -
10 submissions in the last 2 years
vs 16 in the prior period
Consistent review times:
98d avg (recent)
FDA 510(k) Cleared Posterior Cervical Screw System Devices (Product Code NKG)
118 devices
Cleared
Jun 02, 2026
TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems
ZheJiang Decans Medical Devices Co., Ltd.
Orthopedic
249d
Cleared
Mar 16, 2026
CarboClear® Posterior Cervical Screw System
CarboFix Orthopedics , Ltd.
Orthopedic
89d
Cleared
Jan 21, 2026
Infinity™ OCT System
Medtronic Sofamor Danek USA, Inc.
Orthopedic
30d
Cleared
Nov 12, 2025
CMORE® CT System
Icotec AG
Orthopedic
110d
Cleared
Oct 24, 2025
Infinity™ OCT System
Medtronic Sofamor Danek USA, Inc.
Orthopedic
29d
Cleared
Jun 25, 2025
ANAX™ OCT Spinal System
Cg Medtech Co., Ltd.
Orthopedic
20d
Cleared
May 20, 2025
Sovereign Posterior Cervical System
Met One Technologies, LLC
Orthopedic
57d
Cleared
May 13, 2025
Freedom Posterior Cervical Screws
Signature Orthopaedics Pty, Ltd.
Orthopedic
249d
Cleared
Apr 04, 2025
Virage® OCT Spinal Fixation System
Highridge Medical, LLC
Orthopedic
58d
Cleared
Nov 19, 2024
EUROPA™ Posterior Cervical Fusion System
MiRus, LLC
Orthopedic
88d
Cleared
Mar 27, 2024
CarboClear® Posterior Cervical Screw System
CarboFix Orthopedics , Ltd.
Orthopedic
100d
Cleared
Mar 14, 2024
QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments
Globus Medical, Inc.
Orthopedic
265d
Cleared
Nov 27, 2023
Statera-C™ Spinal System
K&J Consulting Corp.
Orthopedic
59d
Cleared
Nov 22, 2023
Posterior Cervical Spine System
Double Medical Technology, Inc.
Orthopedic
58d
Cleared
Nov 09, 2023
SYMPHONY OCT System
Medos International SARL
Orthopedic
38d
Cleared
Sep 27, 2023
VySpan™ PCT System
Vy Spine, LLC
Orthopedic
68d
Cleared
Aug 03, 2023
NorthStar OCT System
Seaspine, Inc.
Orthopedic
58d
Cleared
Jul 20, 2023
CastleLoc-S Posterior Cervical Fixation System
L & K Biomed Co., Ltd.
Orthopedic
28d
Cleared
Jul 10, 2023
Edge Upper Cervical System
Spinal Simplicity, LLC
Orthopedic
431d
Cleared
May 02, 2023
Cortium™
Ulrich Medical USA
Orthopedic
57d
Cleared
Feb 24, 2023
VySpan™ PCT System
Vy Spine, LLC
Orthopedic
64d
Cleared
Jan 11, 2023
INFINITY OCT System
Medtronic Sofamor Danek USA, Inc.
Orthopedic
27d
Cleared
Nov 18, 2022
COSY Cervicothoracic Occipital Rod-Screw System
Signus Medizintechnik GmbH
Orthopedic
256d
Cleared
Nov 03, 2022
Black Diamond™ POCT Spinal System
Osseus Fusion Systems
Orthopedic
108d
About Product Code NKG - Regulatory Context
510(k) Submission Activity
118 total 510(k) submissions under product code NKG since 2015, with 118 receiving FDA clearance (average review time: 96 days).
Submission volume has declined in recent years - 10 submissions in the last 24 months compared to 16 in the prior period.
FDA 510(k) Review Time - NKG Product Code
FDA review times for NKG submissions have been consistent, averaging 98 days recently vs 96 days historically.
NKG devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →