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 Medtronic Sofamor Danek USA, Inc., Medtronic Sofamor Danek and Depuy Spine, Inc..
915
Total
915
Cleared
101d
Avg days
2003
Since
Declining activity -
60 submissions in the last 2 years
vs 84 in the prior period
Consistent review times:
114d avg (recent)
FDA 510(k) Cleared Thoracolumbosacral Pedicle Screw System Devices (Product Code NKB)
915 devices
Cleared
Oct 29, 2026
Virata Spinal Fixation System
SeaSpine Orthopedics Corporation
Orthopedic
90d
Cleared
Oct 02, 2026
AnyPlus II Spinal Fixation System
GS Medical Co., Ltd.
Orthopedic
171d
Cleared
Oct 01, 2026
NOVIX Pedicle Screw System
Tdm Co., Ltd.
Orthopedic
30d
Cleared
Sep 30, 2026
Duet™ Spinal Fixation System
Duet Spine Holdings, LLC
Orthopedic
61d
Cleared
Sep 30, 2026
SAS MIS Pelvic Incidence Rods
Spinal Alignment Solutions, Inc.
Orthopedic
20d
Cleared
Sep 27, 2026
Kentrospine Viktr-MIS® Pedicle screw system
Rivarp Medical Pvt., Ltd.
Orthopedic
446d
Cleared
Sep 23, 2026
iFuse Granite Onyx™ Implant System
SI-BONE, Inc.
Orthopedic
93d
Cleared
Sep 17, 2026
FRAXION Spinal Fixation System
Ortler Global Tibbi Gerecler Anonim Sirketi
Orthopedic
87d
Cleared
Sep 14, 2026
RIVA® Posterior Fixation System with NanoACTIV Surface Technology
Xenix Medical
Orthopedic
77d
Cleared
Sep 04, 2026
KHEIRON® Spinal Fixation System, including patient specific K-ROD
S.M.A.I.O
Orthopedic
25d
Cleared
Jul 24, 2026
Tiger 2 System
Zavation Medical Products, LLC
Orthopedic
226d
Cleared
Jul 24, 2026
QUATTRO Spinal system (Open Configuration)
MANTIZ Co., Ltd.
Orthopedic
170d
Cleared
Jul 14, 2026
Invictus® Small Stature Spinal Fixation System
Alphatec Spine, Inc.
Orthopedic
88d
Cleared
Jul 01, 2026
KHEIRON® Spinal Fixation System, including patient specific K-ROD
S.M.A.I.O
Orthopedic
215d
Cleared
Jun 17, 2026
“Socko” Vimax Spinal Fixation System
Socko Medical Co., Ltd.
Orthopedic
268d
Cleared
Jun 09, 2026
ChanPin Pedicle Screw Spinal System
Chanpin Medtak Co., Ltd.
Orthopedic
412d
Cleared
May 15, 2026
Varion Thoracolumbar Fixation System
Kyocera Medical Technologies Inc. (KMTI)
Orthopedic
51d
Cleared
May 07, 2026
SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System
Globus Medical, Inc.
Orthopedic
164d
Cleared
May 05, 2026
AccelFix Spinal Fixation System
L & K Biomed Co., Ltd.
Orthopedic
29d
Cleared
May 01, 2026
PERLA® TL Posterior Thoraco-lumbar Fixation System
Spineart SA
Orthopedic
141d
Cleared
Apr 29, 2026
LEO Spinal System
ZheJiang Decans Medical Devices Co., Ltd.
Orthopedic
260d
Cleared
Apr 28, 2026
M.U.S.T. Pedicle Screw System - Extension
Medacta International S.A.
Orthopedic
140d
Cleared
Apr 21, 2026
CD Horizon™ ModuLeX™ Fenestrated Screw Set
Medtronic Sofamor Danek USA, Inc.
Orthopedic
88d
Cleared
Apr 16, 2026
ARx® SAI Implant System
Life Spine, Inc.
Orthopedic
107d
About Product Code NKB - Regulatory Context
510(k) Submission Activity
915 total 510(k) submissions under product code NKB since 2003, with 915 receiving FDA clearance (average review time: 101 days).
Submission volume has declined in recent years - 60 submissions in the last 24 months compared to 84 in the prior period.
FDA 510(k) Review Time - NKB Product Code
FDA review times for NKB submissions have been consistent, averaging 114 days recently vs 100 days historically.
NKB devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →