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
433–456 of 905
Cleared May 26, 2016
Threshold Pedicular Fixation System, Palisade Pedicular Fixation System
K160980
Spineology, Inc.
Orthopedic · 49d
Cleared May 18, 2016
JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector
K160226
Implanet, S.A.
Orthopedic · 110d
Cleared May 04, 2016
Xenco Medical Pedicle Screw System
K160986
Xenco Medical, LLC
Orthopedic · 26d
Cleared Apr 27, 2016
Syzygy Stabilization System
K153152
Amendia, Inc.
Orthopedic · 177d
Cleared Apr 26, 2016
Inertia Pedicle Screw and Deformity Correxxion System
K153453
Nexxt Spine, LLC
Orthopedic · 148d
Cleared Apr 22, 2016
PASS LP Spinal System
K153413
Medicrea International SA
Orthopedic · 149d
Cleared Apr 22, 2016
Revolution Spinal Fixation System
K160216
Intelligent Implant Systems, LLC
Orthopedic · 84d
Cleared Apr 13, 2016
Diplomat® Spinal System
K151704
Signus Medizintechnik GmbH
Orthopedic · 294d
Cleared Apr 12, 2016
icotec Pedicle System
K151977
Icotec AG
Orthopedic · 270d
Cleared Mar 23, 2016
Response 5.5 Spine System
K160466
OrthoPediatrics Corp.
Orthopedic · 33d
Cleared Mar 08, 2016
Erisma-LP Spinal Fixation System
K153326
Clariance, Sas
Orthopedic · 110d
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 12, 2016
Adena-Zina System
K152781
Shanghai Sanyou Medical Co, Ltd.
Orthopedic · 140d
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 28, 2016
Seneka II Polyscrew Pedicle Fixation System
K153525
Senecka Spine
Orthopedic · 50d
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 20, 2015
Libra Pedicle Screw System
K151770
Spinal Balance, Inc.
Orthopedic · 143d
Cleared Nov 17, 2015
RANGE/DENALI/MESA Spinal System
K153031
K2m, Incorporated
Orthopedic · 29d
Cleared Nov 13, 2015
Polaris Spinal System
K151974
Biomet Spine
Orthopedic · 120d