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
769–792 of 905
Cleared Oct 10, 2008
NUVASIVE SPHERX SYSTEM
K082332
Nuvasive, Inc.
Orthopedic · 57d
Cleared Oct 08, 2008
LDR SPINE EASYSPINE SYSTEM
K082592
Ldr Spine USA
Orthopedic · 30d
Cleared Oct 07, 2008
SYNERGY SPINAL SYSTEM (6.35 POLARIS)
K081952
Biomet Spine
Orthopedic · 90d
Cleared Oct 07, 2008
RADIUS SPINAL SYSTEM, VITALLIUM ROD #486613601
K082608
Stryker Spine
Orthopedic · 29d
Cleared Sep 15, 2008
BLACKSTONE PEDICLE SCREW SYSTEM
K081684
Blackstone Medical, Inc.
Orthopedic · 90d
Cleared Sep 10, 2008
EXPEDIUM SPINE SYSTEM
K081898
Depuy Spine, Inc.
Orthopedic · 69d
Cleared Sep 03, 2008
MODIFICATIONS TO EXPEDIUM SPINE SYSTEM
K082195
Depuy Spine, Inc.
Orthopedic · 30d
Cleared Jun 17, 2008
MODIFICATION TO CORAL SPINAL SYSTEM
K081414
Theken Spine, LLC
Orthopedic · 28d
Cleared Jun 16, 2008
AXIS FIXATION SYSTEM
K062254
Medtronic Sofamor Danek, Inc.
Orthopedic · 682d
Cleared May 30, 2008
EXPEDIUM 4.5MM SPINE SYSTEM
K081252
Depuy Spine, Inc.
Orthopedic · 28d
Cleared May 28, 2008
REVERE UNIPLANAR SCREWS
K081195
Globus Medical, Inc.
Orthopedic · 30d
Cleared May 15, 2008
MODIFICATION TO VIPER SPINE SYSTEM
K073562
Depuy Spine, Inc.
Orthopedic · 148d
Cleared May 08, 2008
MODIFICATION TO EXPEDIUM SPINE SYSTEM
K080313
Depuy Spine, Inc.
Orthopedic · 92d
Cleared Apr 30, 2008
XIA SPINAL SYSTEM, STAINLESS STEEL UNI-PLANAR SCREWS
K080928
Stryker Spine
Orthopedic · 28d
Cleared Apr 04, 2008
EXPEDIUM 4.5MM SPINE SYSTEM
K073364
Depuy Spine, Inc.
Orthopedic · 126d
Cleared Mar 20, 2008
PIONEER LOWTOP SPINAL ROD SYSTEM
K080504
Pioneer Surgical Technology
Orthopedic · 24d
Cleared Mar 20, 2008
PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM
K080518
Pioneer Surgical Technology
Orthopedic · 24d
Cleared Mar 10, 2008
MODIFICATION TO ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
K080258
Endius, Inc.
Orthopedic · 39d
Cleared Feb 11, 2008
ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM
K073510
Endius, Inc.
Orthopedic · 60d
Cleared Jan 30, 2008
ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
K073267
Endius, Inc.
Orthopedic · 71d
Cleared Jan 29, 2008
VALEO PEDICLE SCREW SPINAL SYSTEM
K073430
Amedica Corp.
Orthopedic · 54d
Cleared Jan 04, 2008
LIFE SPINE CROSS CONNECTOR
K073480
Life Spine
Orthopedic · 24d
Cleared Jan 03, 2008
H-LINK INTEGRATED ROD
K073517
Globus Medical, Inc.
Orthopedic · 20d
Cleared Dec 20, 2007
MALIBU SPINAL SYSTEM
K072605
Seaspine, Inc.
Orthopedic · 94d