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
577–600 of 905
Cleared Apr 01, 2013
STREAMLINE MIS SPINAL FIXATION SYSTEM
K130286
Pioneer Surgical Technology, Inc.
Orthopedic · 55d
Cleared Mar 28, 2013
FIREBIRD SPINAL FIXATION SYSTEM
K130176
Orthofix
Orthopedic · 62d
Cleared Mar 12, 2013
S4 SPINAL SYSTEM
K123939
Aesculap Implant Systems, Inc.
Orthopedic · 82d
Cleared Mar 06, 2013
NAUTILUS SPINAL SYSTEM
K123373
Life Spine
Orthopedic · 125d
Cleared Mar 04, 2013
UCENTUM
K123717
Ulrich GmbH & Co. KG
Orthopedic · 90d
Cleared Feb 25, 2013
POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM
K123549
Biomet Spine (Aka Ebi, LLC)
Orthopedic · 98d
Cleared Feb 22, 2013
CD HORIZON SPINAL SYSTEM
K123809
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 73d
Cleared Feb 14, 2013
ILLICO MIS POSTERIOR FIXATION SYSTEM
K123623
Alphatec Spine, Inc.
Orthopedic · 83d
Cleared Feb 01, 2013
EASYSPINE SYSTEM
K123134
Ldr Spine USA, Inc.
Orthopedic · 119d
Cleared Jan 25, 2013
MEDYSSEY CANNULATED PEDICLE SCREW
K121670
Medyssey Co, Ltd.
Orthopedic · 233d
Cleared Dec 12, 2012
MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM
K122571
Seaspine, Inc.
Orthopedic · 111d
Cleared Dec 12, 2012
S4 SPINAL SYSTEM
K123352
Aesculap Implant Systems, Inc.
Orthopedic · 42d
Cleared Dec 07, 2012
ES2 SPINAL SYSTEM MODEL 48280XXXX
K122845
Stryker Spine
Orthopedic · 81d
Cleared Dec 03, 2012
FIREBIRD SPINAL FIXATION SYSTEM, PHOENIX MIS SPINAL FIXATION SYSTEM
K122901
Orthofix
Orthopedic · 73d
Cleared Dec 03, 2012
POLARIS SPINAL SYSTEM - BALLISTA II RODS
K123451
Biomet Spine (Aka Ebi, LLC)
Orthopedic · 24d
Cleared Nov 20, 2012
VICEROY SPINAL SYSTEM
K122229
Torrey Spine
Orthopedic · 117d
Cleared Nov 16, 2012
CD HORIZON SPIRE Z SPINAL SYSTEM
K123246
Medtronic Sofamor Danek
Orthopedic · 30d
Cleared Nov 05, 2012
DYMAXEON SPINE SYSTEM
K121786
B2b Spine Pty, Ltd.
Orthopedic · 140d
Cleared Oct 05, 2012
TIGER SPINE SYSTEM
K121728
Corelink, LLC
Orthopedic · 115d
Cleared Oct 03, 2012
CD HORIZON SPINAL SYSTEM
K122862
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 16d
Cleared Oct 01, 2012
TANGORS MULTIFUNCTIONAL POSTERIOR SYSTEM
K120891
Ulrich GmbH & Co. KG
Orthopedic · 192d
Cleared Oct 01, 2012
REVERE STABILIZATION SYSTEM
K122226
Globus Medical, Inc.
Orthopedic · 67d
Cleared Sep 28, 2012
CD HORIZON SPINAL SYSTEM
K122433
Medtronic Sofamor Danek, Inc.
Orthopedic · 49d
Cleared Sep 21, 2012
DALI SPINAL FIXATION SYSTEM
K121568
Accel Spine
Orthopedic · 115d