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
457–480 of 905
Cleared Nov 05, 2015
CD HORIZON Spinal System
K152248
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 87d
Cleared Oct 28, 2015
Genesys Spine TiLock2 Spinal System
K152039
Genesys Spine
Orthopedic · 98d
Cleared Oct 27, 2015
CD HORIZON Spinal System
K152457
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 60d
Cleared Oct 16, 2015
Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle Screw System, Valencia MIS Pedicle Screw System
K151648
Altus Partners, LLC
Orthopedic · 120d
Cleared Oct 08, 2015
STERISPINE PS
K151921
Safe Orthopaedics
Orthopedic · 87d
Cleared Oct 05, 2015
STERISPINE PS
K151747
Safe Orthopaedics
Orthopedic · 98d
Cleared Sep 30, 2015
Seneka I Polyscrew Pedicle Fixation System
K151849
Senecka Spine
Orthopedic · 85d
Cleared Sep 17, 2015
Everest Spinal System
K151727
K2m, Inc.
Orthopedic · 83d
Cleared Sep 04, 2015
Xenco Medical Pedicle Screw System
K151733
Xenco Medical, LLC
Orthopedic · 70d
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
Cleared Aug 21, 2015
Reform Pedicle Screw System
K151422
Precision Spine, Inc.
Orthopedic · 85d
Cleared Aug 10, 2015
Everest Spinal System
K151216
K2m, Inc.
Orthopedic · 96d
Cleared Jul 17, 2015
ProMIS Fixation System
K150380
Premia Spine, Ltd.
Orthopedic · 154d
Cleared Jul 14, 2015
Nautilus Spinal System
K151196
Life Spine, Inc.
Orthopedic · 70d
Cleared Jul 07, 2015
Reform Pedicle Screw System
K150856
Precision Spine, Inc.
Orthopedic · 98d
Cleared Jul 07, 2015
Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System
K151488
Orthofix, Inc.
Orthopedic · 35d
Cleared Jun 24, 2015
GALAXY MIS Screw System
K143110
Bm Korea
Orthopedic · 238d
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 15, 2015
Dymaxeon Spine System
K150184
Back 2 Basics Direct, LLC
Orthopedic · 139d
Cleared Jun 12, 2015
Iliad Pedicle Screw System and Zenius Pedicle Screw System
K142835
Medyssey USA, Inc.
Orthopedic · 255d
Cleared Jun 03, 2015
Mercury Spinal System
K151215
Spinal Elements, Inc.
Orthopedic · 28d
Cleared May 22, 2015
APEX-DL Spine System
K143683
Spinecraft, LLC
Orthopedic · 149d
Cleared May 22, 2015
Response 5.5/6.0 Spine System
K150600
OrthoPediatrics Corp.
Orthopedic · 73d