NKB · Class II · 21 CFR 888.3070

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..

905
Total
905
Cleared
101d
Avg days
2003
Since
905 devices
385–408 of 905
Cleared Aug 10, 2015
Everest Spinal System
K151216
K2m, Inc.
Orthopedic · 96d
Cleared Jul 14, 2015
Nautilus Spinal System
K151196
Life Spine, Inc.
Orthopedic · 70d
Cleared Jul 07, 2015
Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System
K151488
Orthofix, Inc.
Orthopedic · 35d
Cleared Jun 18, 2015
Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System, Nex-Link OCT Cervical Plating System, Sequoia Pedicle Screw System including SpeedLink II, ST360º Spinal Fixatoin System, Title 2 Polyaxial Spinal System
K142752
Zimmer Spine, Inc.
Orthopedic · 267d
Cleared Jun 03, 2015
Mercury Spinal System
K151215
Spinal Elements, Inc.
Orthopedic · 28d
Cleared May 22, 2015
Response 5.5/6.0 Spine System
K150600
OrthoPediatrics Corp.
Orthopedic · 73d
Cleared Apr 23, 2015
NuVasive Reline System
K143684
Nu Vasive, Incorporated
Orthopedic · 120d
Cleared Apr 22, 2015
VENUS Spinal Fixation System
K143363
L & K Biomed Co., Ltd.
Orthopedic · 149d
Cleared Apr 08, 2015
CD HORIZON Spinal System, IPC POWEREASE System
K143019
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 170d
Cleared Mar 31, 2015
Range/Denali/Mesa Spinal System
K150325
K2m, Inc.
Orthopedic · 50d
Cleared Mar 16, 2015
Nautilus Spinal System
K150390
Life Spine, Inc.
Orthopedic · 26d
Cleared Feb 13, 2015
CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments
K143375
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 80d
Cleared Feb 12, 2015
NAUTILUS SPINAL SYSTEM AND SOLSTICE OCT SYSTEM
K141222
Life Spine, Inc.
Orthopedic · 276d
Cleared Feb 12, 2015
CD HORIZON Spinal System
K143569
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 58d
Cleared Feb 11, 2015
CD HORIZON SPINAL SYSTEM
K150178
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 16d
Cleared Jan 30, 2015
CREO Stabilization System
K143633
Globus Medical, Inc.
Orthopedic · 39d
Cleared Jan 21, 2015
Everest Spinal System
K142360
K2m, Inc.
Orthopedic · 149d
Cleared Jan 09, 2015
Range/Denali/Mesa Spinal System
K143334
K2m, Inc.
Orthopedic · 50d
Cleared Jan 05, 2015
Arsenal Spinal Fixation System
K143149
Alphatec Spine, Inc.
Orthopedic · 63d
Cleared Jan 02, 2015
FIREBIRD SPINAL FIXATION SYSTEM
K141186
Orthofix, Inc.
Orthopedic · 240d
Cleared Dec 18, 2014
MAS PLIF Fixation system
K142737
Nu Vasive, Incorporated
Orthopedic · 86d
Cleared Dec 18, 2014
Threshold Pedicular Fixation System
K143403
Spineology, Inc.
Orthopedic · 20d
Cleared Dec 11, 2014
IBIS PEDICLE SCREW SYSTEM
K142146
Ortho Development Corp.
Orthopedic · 128d
Cleared Dec 01, 2014
CD HORIZON Spinal System
K142591
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 77d