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
337–360 of 905
Cleared Sep 26, 2017
ROMEO® 2 Posterior Osteosynthesis System
K172101
Spineart
Orthopedic · 76d
Cleared Sep 14, 2017
Range/Denali/Mesa Spinal System
K171832
K2m, Inc.
Orthopedic · 86d
Cleared Aug 31, 2017
Additional VIPER PRIME™ screws with fenestrations
K171570
Medos International SARL
Orthopedic · 93d
Cleared Aug 21, 2017
Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™ Pedicular Fixation System, Palisade™ Pedicular Fixation System
K172107
Spineology, Inc.
Orthopedic · 40d
Cleared Aug 16, 2017
CapSure® PS System
K172175
Spine Wave, Inc.
Orthopedic · 28d
Cleared Aug 01, 2017
M.U.S.T. Combined Set Screws
K171758
Medacta International S.A.
Orthopedic · 48d
Cleared Jul 13, 2017
OpenLoc-L Spinal Fixation System, LnK Spinal Fixation System
K171813
L & K Biomed Co., Ltd.
Orthopedic · 24d
Cleared Jun 02, 2017
Palisade™ Pedicular Fixation System
K171438
Spineology, Inc.
Orthopedic · 17d
Cleared May 25, 2017
M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws
K171170
Medacta International S.A.
Orthopedic · 34d
Cleared May 16, 2017
Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory
K170496
Stryker Corporation
Orthopedic · 88d
Cleared May 11, 2017
CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems
K170679
Medtronic Sofamor Danek
Orthopedic · 66d
Cleared May 05, 2017
Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System, Firebird NXG Spinal Fixation System
K171082
Orthofix, Inc.
Orthopedic · 24d
Cleared May 04, 2017
VIPER PRIME™ Screws with Fenestrations
K170543
Medos International SARL
Orthopedic · 69d
Cleared Apr 14, 2017
Threshold™ Pedicular Fixation System
K170251
Spineology, Inc.
Orthopedic · 77d
Cleared Apr 14, 2017
Threshold™ V2 Pedicular Fixation System
K170255
Spineology, Inc.
Orthopedic · 77d
Cleared Apr 14, 2017
Palisade™ Pedicular Fixation System
K170266
Spineology, Inc.
Orthopedic · 77d
Cleared Apr 14, 2017
Fortress™ Pedicular Fixation System
K170268
Spineology, Inc.
Orthopedic · 77d
Cleared Mar 29, 2017
USS System
K170654
Synthes USA Products, LLC
Orthopedic · 26d
Cleared Mar 09, 2017
SeaSpine® Daytona® Small Stature Spinal System
K163604
SeaSpine Orthopedics Corporation
Orthopedic · 78d
Cleared Mar 09, 2017
NuVasive® Reline® 4.5-5.0 System
K170126
Nu Vasive, Incorporated
Orthopedic · 55d
Cleared Dec 20, 2016
CD HORIZON® Spinal System
K163301
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 28d
Cleared Dec 08, 2016
VIPER PRIME™ additions to the VIPER® System
K162912
Medos International SARL
Orthopedic · 52d
Cleared Nov 16, 2016
CD HORIZON® Spinal System
K162379
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 84d
Cleared Oct 21, 2016
M.U.S.T. Pedicle Screw System
K162061
Medacta International S.A.
Orthopedic · 87d