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., CarboFix Orthopedics , Ltd. and L & K Biomed Co., Ltd..

899
Total
899
Cleared
100d
Avg days
2003
Since
899 devices
193–216 of 899
Cleared Dec 03, 2020
LineSider™ Spinal System
K203367
Integrity Implants, Inc.
Orthopedic · 17d
Cleared Nov 25, 2020
CarboClear X Pedicle Screw System
K203317
CarboFix Orthopedics , Ltd.
Orthopedic · 15d
Cleared Nov 23, 2020
Invictus™ Spinal Fixation System
K203056
Alphatec Spine, Inc.
Orthopedic · 46d
Cleared Nov 12, 2020
Calvary Spine Pedicle Screw System
K201568
Calvary Spine, LLC
Orthopedic · 154d
Cleared Nov 05, 2020
Salvo® Spine System
K202476
Spine Wave, Inc.
Orthopedic · 69d
Cleared Oct 28, 2020
LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System
K200790
L & K Biomed Co., Ltd.
Orthopedic · 216d
Cleared Oct 26, 2020
ACURA Stabilization System
K200937
Indius Medical Technologies Pvt. , Ltd.
Orthopedic · 201d
Cleared Oct 26, 2020
Cannulated Power Driver Attachment
K202528
K2m, Inc.
Orthopedic · 55d
Cleared Oct 23, 2020
Wiltrom Spinal Fixation System
K202894
Wiltrom Corporation Limited
Orthopedic · 25d
Cleared Oct 21, 2020
Trivergent Spinal Fixation System
K201427
Benvenue Medical, Inc.
Orthopedic · 145d
Cleared Oct 20, 2020
AccelFix Spinal Fixation System
K200794
L & K Biomed Co., Ltd.
Orthopedic · 208d
Cleared Oct 19, 2020
CD Horizon Spinal System
K202771
Medtronic
Orthopedic · 28d
Cleared Oct 15, 2020
Invictus™ OsseoScrew® System
K202327
Alphatec Spine, Inc.
Orthopedic · 59d
Cleared Oct 05, 2020
KHEIRON® Spinal Fixation System
K201659
S.M.A.I.O
Orthopedic · 109d
Cleared Sep 10, 2020
CD Horizon™ Spinal System
K201407
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 105d
Cleared Sep 08, 2020
CD Horizon Spinal System
K202328
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 22d
Cleared Aug 18, 2020
ORION Spinal System
K190600
Orion Biotech, Inc.
Orthopedic · 529d
Cleared Aug 11, 2020
Mega Plus MIS Spine System
K200981
Bk Meditech, Co., Ltd.
Orthopedic · 119d
Cleared Aug 07, 2020
CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw System
K201926
CarboFix Orthopedics , Ltd.
Orthopedic · 28d
Cleared Jul 30, 2020
Sterispine™ PS
K201648
Safe Orthopaedics
Orthopedic · 42d
Cleared Jul 22, 2020
Pedicle Screw System
K201751
Black Box Medical, LLC
Orthopedic · 26d
Cleared Jul 22, 2020
True Tulip System, True M.I.S. System
K201780
Innovative Surgical Designs, Inc.
Orthopedic · 22d
Cleared Jun 16, 2020
Spinal Fixation System
K190408
Shangdong Kangsheng Medical Devices Co., Ltd.
Orthopedic · 481d
Cleared Jun 02, 2020
Altus Spine Pedicle Screw System
K200322
Altus Partners, LLC
Orthopedic · 113d