NKG · Class II · 21 CFR 888.3075

FDA Product Code NKG: Posterior Cervical Screw System

FDA product code NKG covers posterior cervical screw systems.

These implants are used to stabilize the posterior cervical spine through screw-rod or screw-plate constructs anchored to the lateral masses or pedicles of the cervical vertebrae. They are used in the surgical treatment of cervical instability, fractures, deformities, and tumor resection.

NKG devices are Class II medical devices, regulated under 21 CFR 888.3075 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include Medtronic Sofamor Danek USA, Inc., Orthofix, Inc. and Medos International SARL.

118
Total
118
Cleared
96d
Avg days
2015
Since
118 devices
73–96 of 118
Cleared Aug 18, 2017
Connector System
K172194
Orthofix, Inc.
Orthopedic · 28d
Cleared Aug 08, 2017
YUKON OCT Spinal System
K171444
K2m, Inc.
Orthopedic · 84d
Cleared Aug 01, 2017
M.U.S.T. MINI Posterior Cervical Screws System
K171369
Medacta International S.A.
Orthopedic · 83d
Cleared May 18, 2017
The Solstice OCT System
K170804
Life Spine, Inc.
Orthopedic · 62d
Cleared May 11, 2017
Connector System
K170647
Orthofix, Inc.
Orthopedic · 69d
Cleared May 01, 2017
The Cranial Fusion System
K162266
Life Spine, Inc.
Orthopedic · 263d
Cleared Feb 07, 2017
Proficient™ Posterior Cervical Spine System
K162639
Spine Wave, Inc.
Orthopedic · 138d
Cleared Nov 03, 2016
CastleLoc-S Posterior Cervical Fixation System
K162136
L & K Biomed Co., Ltd.
Orthopedic · 94d
Cleared Sep 21, 2016
QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments
K161591
Globus Medical, Inc.
Orthopedic · 104d
Cleared Jul 21, 2016
PathLoc-C Posterior Cervical Fixation System
K153439
L & K Biomed Co., Ltd.
Orthopedic · 237d
Cleared Jun 28, 2016
Gibralt® Spine System and Gibralt® Occipital Spine System
K160697
Exactech, Inc.
Orthopedic · 106d
Cleared Feb 16, 2016
Zimmer Virage OCT Spinal Fixation System
K153631
Zimmer Spine, Inc.
Orthopedic · 60d
Cleared Jan 25, 2016
Perla Posterior Cervico-Thoracic Fixation system
K153386
Spineart
Orthopedic · 63d
Cleared Jan 07, 2016
VuePoint OCT System
K153336
Nu Vasive, Incorporated
Orthopedic · 49d
Cleared Oct 28, 2015
VERTEX(r) Reconstruction System
K152338
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 70d
Cleared Oct 21, 2015
NuVasive VuePoint II OCT System
K150474
Nu Vasive, Incorporated
Orthopedic · 240d
Cleared Sep 03, 2015
Lotus Posterior Cervical/Thoracic Spinal System
K151705
Spinal Elements, Inc.
Orthopedic · 71d
Cleared Jul 09, 2015
OASYS(r) System
K151755
Stryker Corporation
Orthopedic · 10d
Cleared Jun 24, 2015
Virage OCT Spinal Fixation System
K151031
Zimmer Spine, Inc.
Orthopedic · 68d
Cleared Jun 04, 2015
ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS
K150552
Globus Medical, Inc.
Orthopedic · 92d
Cleared May 15, 2015
Centurion POCT System
K150822
Orthofix, Inc.
Orthopedic · 49d
Cleared May 12, 2015
OASYS System
K150539
Stryker Corporation
Orthopedic · 70d
Cleared Feb 06, 2015
VERTEX Reconstruction System
K143471
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 63d
Cleared Jan 20, 2015
Synapse Occipital-Cervical-Thoracic (OCT) System
K142838
Synthes USA Products, LLC
Orthopedic · 112d