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
553–576 of 905
Cleared Dec 17, 2013
MANTIS & MANTIS REDUX SPINAL SYSTEM, RADIUS SPINAL SYSTEM, TRIO & TRIO+ SPINAL FIXATION SYSTEMS, AND TRIO TRAUMA SPINAL
K133188
Stryker Spine
Orthopedic · 61d
Cleared Dec 17, 2013
ST360 DEGREES SPINAL FIXATION SYSTEM
K133291
Zimmer Spine, Inc.
Orthopedic · 53d
Cleared Dec 06, 2013
CD HORIZON SPINAL SYSTEM
K132328
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 133d
Cleared Nov 27, 2013
TITLE 2 POLYAXIAL SPINAL SYSTEM
K133086
Zimmer Spine, Inc.
Orthopedic · 58d
Cleared Nov 25, 2013
CD HORIZON SPINAL SYSTEM
K132639
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 94d
Cleared Nov 25, 2013
PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
K132884
Zimmer Spine, Inc.
Orthopedic · 73d
Cleared Nov 20, 2013
APEX SPINE SYSTEM
K132603
Spinecraft, LLC
Orthopedic · 92d
Cleared Oct 31, 2013
GSB GLOBAL SPINAL BALANCE SYSTEM
K132014
Nuvasive, Inc.
Orthopedic · 122d
Cleared Oct 28, 2013
NAUTILUS SPINAL SYSTEM
K132866
Life Spine, Inc.
Orthopedic · 45d
Cleared Oct 08, 2013
CD HORIZON SPINAL SYSTEM
K132471
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 62d
Cleared Oct 03, 2013
NAUTILUS SPINAL SYSTEM
K132760
Life Spine, Inc.
Orthopedic · 29d
Cleared Sep 10, 2013
TIGER SPINE SYSTEM
K131250
Corelink, LLC
Orthopedic · 131d
Cleared Sep 04, 2013
SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM
K131980
Zimmer Spine, Inc.
Orthopedic · 68d
Cleared Aug 23, 2013
LLIAD, KORA, ZENIUS PEDICLE SCREW SYSTEM
K131878
Medyssey USA, Inc.
Orthopedic · 60d
Cleared Aug 20, 2013
PAGODA PEDICLE SCREW SYSTEM
K131785
Ortho Development Corp.
Orthopedic · 63d
Cleared Aug 07, 2013
FIREBIRD SPINAL FIXATION SYSTEM
K130932
Orthofix, Inc.
Orthopedic · 125d
Cleared Aug 06, 2013
CD HORIZON SPINAL SYSTEM
K132111
Medtronic Sofamor Danek USA
Orthopedic · 28d
Cleared Jun 27, 2013
STREAMLINE TL SPINAL SYSTEM
K131100
Pioneer Surgical Technology, Inc.
Orthopedic · 69d
Cleared Jun 20, 2013
EXPEDIUM SPINE SYSTEM
K130877
Medos International SARL
Orthopedic · 83d
Cleared May 21, 2013
SOLANAS POSTERIOR STABILIZATION SYSTEM
K131119
Alphatec Spine, Inc.
Orthopedic · 29d
Cleared May 03, 2013
STERISPINE PS PEDICLE SCREW
K130632
Safe Orthopaedics
Orthopedic · 56d
Cleared Apr 19, 2013
INSTINCT JAVA SYSTEM
K123552
Zimmer Spine
Orthopedic · 151d
Cleared Apr 11, 2013
S4 SPINAL SYSTEM
K130291
Aesculap Implant System, Inc.
Orthopedic · 64d
Cleared Apr 10, 2013
CD HORIZON SPINAL SYSTEM
K130646
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 30d