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
673–696 of 905
Cleared Jul 21, 2011
GENESYS SPINE TILOCK SYSTEM
K103671
Genesys Spine
Orthopedic · 217d
Cleared Jul 13, 2011
ATLAS SPINE PEDICLE SCREW SYSTEM
K110842
Atlas Spine, Inc.
Orthopedic · 110d
Cleared Jul 12, 2011
SOLANAS AVALON POSTERIOR FIXATION SYSTEM
K111076
Alphatec Spine, Inc.
Orthopedic · 85d
Cleared Jul 06, 2011
REVLOK FENESTRATED SCREW SYSTEM
K110280
Globus Medical, Inc.
Orthopedic · 156d
Cleared Jul 06, 2011
VIPER SYSTEMS
K111571
Johnson & Johnson
Orthopedic · 30d
Cleared Jun 08, 2011
TSRH SPINAL SYSTEM
K110070
Medtronic Sofamor Danck USA, Inc.
Orthopedic · 149d
Cleared May 25, 2011
LEUCADIA PEDICLE SCREW SYSTEM
K110588
Phygen, LLC
Orthopedic · 84d
Cleared May 23, 2011
TSRH SPINAL SYSTEM
K110676
Medtronic Sofamor Danek
Orthopedic · 74d
Cleared May 12, 2011
STREAMLINE TL SPINAL SYSTEM
K110692
Pioneer Surgical Technology, Inc.
Orthopedic · 62d
Cleared May 05, 2011
ISSYS LP SPINAL FIXATION SYSTEM
K111099
Custom Spine, Inc.
Orthopedic · 15d
Cleared Apr 01, 2011
EXPEDIUM SYSTEM, VIPER SYSTEM
K110216
Depuy Spine, Inc.
Orthopedic · 66d
Cleared Mar 25, 2011
LANX SPINAL SYSTEM
K103237
Lanx, Inc.
Orthopedic · 143d
Cleared Mar 17, 2011
REVERE SACRAL PLATES
K103072
Globus Medical, Inc.
Orthopedic · 150d
Cleared Mar 07, 2011
QUANTUM SPINAL SYSTEM, QUANTUM MIS
K101790
Pioneer Surgical Technology
Orthopedic · 252d
Cleared Mar 04, 2011
TRIO TRAUMA SPINAL SYSTEM
K103292
Stryker Corporation
Orthopedic · 116d
Cleared Mar 02, 2011
LAGUNA PEDICLE SCREW SYSTEM
K103748
Phygen, LLC
Orthopedic · 69d
Cleared Feb 17, 2011
SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM
K103383
Spartek Medical, Inc.
Orthopedic · 91d
Cleared Feb 17, 2011
EXPEDIUM SPINE SYSTEM, MOSS MIAMI SPINE SYSTEM
K103490
Johnson & Johnson
Orthopedic · 83d
Cleared Jan 18, 2011
VEPER SYSTEM, EXPEDIUM SYSTEM
K103133
Depuy Spine, Inc.
Orthopedic · 85d
Cleared Jan 05, 2011
SYNTHES 6.0 COCR AND CPT TI-3 RODS
K103287
Synthes Spine
Orthopedic · 65d
Cleared Dec 23, 2010
TSRH SPINAL SYSTEM
K103049
Medtronic Sofamor Danek
Orthopedic · 69d
Cleared Dec 07, 2010
VIPER SYSTEM, EXPEDIUM SYSTEM
K101993
Depuy Spine, Inc.
Orthopedic · 145d
Cleared Dec 01, 2010
NUVASIVE SPHERX II -MAS DEFORMITY SPINAL SYSTEM
K102514
Nuvasive, Inc.
Orthopedic · 91d
Cleared Nov 17, 2010
CD HORIZON SPINAL SYSTEM
K102555
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 71d