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
793–816 of 905
Cleared Dec 13, 2007
BEACON STABILIZATION SYSTEM
K073172
Globus Medical, Inc.
Orthopedic · 30d
Cleared Dec 07, 2007
ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM
K072840
Endius, Inc.
Orthopedic · 64d
Cleared Dec 06, 2007
EXPEDIUM SPINE SYSTEM
K073126
Depuy Spine, Inc.
Orthopedic · 30d
Cleared Dec 06, 2007
MANTIS SPINAL SYSTEM
K073151
Stryker Corp.
Orthopedic · 28d
Cleared Nov 19, 2007
VALEO PEDICLE SCREW SPINAL SYSTEM
K072022
Amedica Corp.
Orthopedic · 119d
Cleared Nov 16, 2007
INNOVASIS EXCELLA SPINAL SYSTEM, EXCELLA-M (MONOAXIAL SCREWS), EXCELLA-P (POLYAXIAL SCREWS)
K071921
Innovasis, Inc.
Orthopedic · 127d
Cleared Oct 12, 2007
MERCURY SPINAL SYSTEM
K071914
Spinal Elements, Inc.
Orthopedic · 93d
Cleared Sep 28, 2007
MODIFICATION TO TSRH SPINAL SYSTEM
K072429
Medtronic Sofamor Danek
Orthopedic · 30d
Cleared Sep 18, 2007
EXPEDIUM SPINE SYSTEM
K070387
Depuy Spine, Inc.
Orthopedic · 221d
Cleared Sep 18, 2007
MODIFICATION TO:TSRH SPINAL SYSTEM
K072317
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 29d
Cleared Sep 06, 2007
ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
K070282
Endius, Inc.
Orthopedic · 220d
Cleared Sep 05, 2007
ST360 SPINAL FIXATION SYSTEM, MODEL 07.0029-7500.5600
K072183
Zimmer Spine, Inc.
Orthopedic · 30d
Cleared Aug 27, 2007
STRYKER SPINE XIA III SPINAL SYSTEM
K071373
Stryker Spine
Orthopedic · 103d
Cleared Aug 22, 2007
CORAL PEDICLE SCREW SYSTEM
K070962
Theken Spine, LLC
Orthopedic · 139d
Cleared Aug 20, 2007
MODIFICATION TO SOLANAS POSTERIOR STABILIZATION SYSTEM
K071380
Alphatec Spine, Inc.
Orthopedic · 95d
Cleared Aug 01, 2007
MODIFICATION TO: VIPER SPINE SYSTEM
K071860
Depuy Spine, Inc.
Orthopedic · 27d
Cleared Jul 13, 2007
DEVICE MODIFICATION TO RADIUS SPINAL SYSTEM
K070631
Stryker Spine
Orthopedic · 128d
Cleared Jul 10, 2007
EXPEDIUM SPINE SYSTEM
K063772
Depuy Spine, Inc.
Orthopedic · 201d
Cleared Jul 03, 2007
QUANTUM SPINAL SYSTEM
K070973
Pioneer Surgical Technology
Orthopedic · 88d
Cleared Jun 28, 2007
MODIFICATIONS TO CD HORIZON SPINAL SYSTEM
K063670
Medtronic Sofamor Danek
Orthopedic · 199d
Cleared Jun 22, 2007
ARX-LINK CROSS CONNECTOR
K070995
Life Spine
Orthopedic · 74d
Cleared May 04, 2007
TRIO PLATE SYSTEM, TRIO SPINAL FIXATION SYSTEM, TRIO+ SPINAL SYSTEM
K070368
Stryker Corp.
Orthopedic · 85d
Cleared Apr 12, 2007
ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM
K070367
Endius, Inc.
Orthopedic · 63d
Cleared Mar 29, 2007
MODIFICATION TO: PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM
K070551
Pioneer Surgical Technology
Orthopedic · 30d