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., CarboFix Orthopedics , Ltd. and L & K Biomed Co., Ltd..

899
Total
899
Cleared
100d
Avg days
2003
Since
899 devices
265–288 of 899
Cleared Apr 11, 2019
Zavation Spinal System
K190317
Zavation Medical Products, LLC
Orthopedic · 57d
Cleared Apr 08, 2019
CREO® Stabilization System, Navigation Instruments, ExcelsiusGPS®
K182375
Globus Medical, Inc.
Orthopedic · 220d
Cleared Apr 08, 2019
Vitality® Spinal Fixation System
K183550
Zimmer Biomet Spine, Inc.
Orthopedic · 109d
Cleared Mar 18, 2019
Zavation Spinal System
K190361
Zavation Medical Products, LLC
Orthopedic · 31d
Cleared Mar 14, 2019
EUROPA Pedicle Screw System
K180337
MiRus, LLC
Orthopedic · 400d
Cleared Mar 13, 2019
Modular Spinal Fixation System
K183430
Life Spine, Inc.
Orthopedic · 92d
Cleared Mar 12, 2019
ISS-JAZZ Screw System and JAZZ CAP SP
K182771
Implanet, S.A.
Orthopedic · 165d
Cleared Feb 13, 2019
NuVasive Reline System
K182974
Nu Vasive, Incorporated
Orthopedic · 110d
Cleared Feb 01, 2019
Pedimax II - Pedicular Screw Spinal System
K180626
Gm Dos Reis Industria E Comerico Ltda.
Orthopedic · 329d
Cleared Jan 22, 2019
EUROPA™ Pedicle Screw System
K182970
MiRus, LLC
Orthopedic · 88d
Cleared Jan 15, 2019
Whistler Modular Pedicle Screw System
K182478
Evolution Spine, LLC
Orthopedic · 127d
Cleared Dec 13, 2018
CBT Screw Fixation System
K181824
U&I Corporation
Orthopedic · 157d
Cleared Dec 12, 2018
LEUCADIA AUTOLOK™ Pedicle Screw System
K182339
Clearview Orthopedic Development, LLC
Orthopedic · 106d
Cleared Dec 12, 2018
Salvo™ Spine System
K182954
Spine Wave, Inc.
Orthopedic · 49d
Cleared Dec 11, 2018
OpenLoc-L Spinal Fixation System
K183168
L & K Biomed Co., Ltd.
Orthopedic · 25d
Cleared Dec 10, 2018
Mega Plus Spine System
K183080
Bk Meditech, Co., Ltd.
Orthopedic · 35d
Cleared Dec 07, 2018
C-Zero Pedicle Screw System, Freedom Pedicle Screw System
K180754
Signature Orthopaedics Pty, Ltd.
Orthopedic · 260d
Cleared Nov 15, 2018
PathLoc-L MIS Spinal System
K183117
L & K Biomed Co., Ltd.
Orthopedic · 6d
Cleared Nov 13, 2018
VersaLink™ Fixation System
K182598
Premia Spine, Ltd.
Orthopedic · 54d
Cleared Oct 27, 2018
ORTHROS™ Posterior Stabilization System
K180980
Camber Spine Technologies, LLC
Orthopedic · 197d
Cleared Oct 23, 2018
FUSE Pedicle Screw System
K182283
Black Box Medical
Orthopedic · 61d
Cleared Oct 18, 2018
OLYMPIC Posterior Spinal Fixation System
K182239
Astura Medical, LLC
Orthopedic · 59d
Cleared Oct 17, 2018
PASS LP Spinal System
K182240
Medicrea International SA
Orthopedic · 58d
Cleared Oct 10, 2018
Cellent Spinal Systems
K172826
Jiangsu Trauhui Medical Instrument Co., Ltd.
Orthopedic · 387d