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
361–384 of 905
Cleared Oct 04, 2016
CD HORIZON® Spinal System
K162494
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 27d
Cleared Sep 28, 2016
NuVasive® Reline® System
K161014
Nu Vasive, Incorporated
Orthopedic · 170d
Cleared Sep 08, 2016
SeaSpine® NewPort™ Spinal System
K161535
SeaSpine Orthopedics Corporation
Orthopedic · 97d
Cleared Aug 22, 2016
PathLoc-L MIS Spinal System
K161766
L & K Biomed Co., Ltd.
Orthopedic · 56d
Cleared Jul 15, 2016
Threshold™ Pedicular Fixation System
K161694
Spineology, Inc.
Orthopedic · 25d
Cleared Jul 01, 2016
Expedium Spine System, VIPER and VIPER 2 Systems
K160904
Medos International SARL
Orthopedic · 91d
Cleared Jun 10, 2016
Arsenal Spinal Fixation System
K161363
Alphatec Spine, Inc.
Orthopedic · 24d
Cleared Jun 09, 2016
NuVasive® Reline® System
K160989
Nu Vasive, Incorporated
Orthopedic · 62d
Cleared May 26, 2016
Mariner Pedicle Screw System
K160902
SeaSpine Orthopedics Corporation
Orthopedic · 55d
Cleared May 26, 2016
Threshold Pedicular Fixation System, Palisade Pedicular Fixation System
K160980
Spineology, Inc.
Orthopedic · 49d
Cleared Mar 23, 2016
Response 5.5 Spine System
K160466
OrthoPediatrics Corp.
Orthopedic · 33d
Cleared Feb 23, 2016
Palisade Pedicular Fixation System
K153323
Spineology, Inc.
Orthopedic · 97d
Cleared Feb 18, 2016
CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with the STEALTHSTATION System, Medtronic Reusable Instruments for Use with the IPC POWEREASE System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION and IPC POWEREASE Systems
K153442
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 83d
Cleared Feb 10, 2016
CD HORIZON Spinal System
K153589
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 56d
Cleared Jan 29, 2016
Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System
K153428
Orthofix, Inc.
Orthopedic · 65d
Cleared Jan 19, 2016
M.U.S.T. Pedicle Screw System
K153664
Medacta International
Orthopedic · 29d
Cleared Dec 30, 2015
Arsenal Spinal Fixation System
K152968
Alphatec Spine, Inc.
Orthopedic · 83d
Cleared Dec 30, 2015
CD HORIZON Spinal System, IPC POWEREASE System
K153463
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 29d
Cleared Dec 02, 2015
XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory
K152632
Stryker Corporation
Orthopedic · 78d
Cleared Nov 05, 2015
CD HORIZON Spinal System
K152248
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 87d
Cleared Oct 27, 2015
CD HORIZON Spinal System
K152457
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 60d
Cleared Sep 17, 2015
Everest Spinal System
K151727
K2m, Inc.
Orthopedic · 83d
Cleared Sep 02, 2015
Fortress Pedicular Fixation System
K152148
Spineology, Inc.
Orthopedic · 30d
Cleared Aug 31, 2015
Vitality Spinal Fixation System
K150896
Zimmer Spine, Inc.
Orthopedic · 151d