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 Medacta International S.A., Medos International SARL and Medtronic Sofamor Danek USA, Inc..

118
Total
118
Cleared
96d
Avg days
2015
Since
118 devices
25–48 of 118
Cleared Sep 09, 2022
NuVasive Reline Cervical System
K221388
Nu Vasive, Incorporated
Orthopedic · 119d
Cleared Jul 01, 2022
Ennovate Cervical Spinal and Occiput System
K213871
Aesculap Implant Systems, LLC
Orthopedic · 200d
Cleared Apr 26, 2022
M.U.S.T. MINI Posterior Cervical Screws System Extension
K220570
Medacta International S.A.
Orthopedic · 57d
Cleared Apr 19, 2022
Infinity™ OCT System and PASS OCT Spinal System
K220810
Medicrea International
Orthopedic · 29d
Cleared Feb 23, 2022
NuVasive Reline Cervical System
K213654
Nu Vasive, Incorporated
Orthopedic · 96d
Cleared Dec 10, 2021
Vy Spine™ VySpan™ PCT System
K213394
Vy Spine, LLC
Orthopedic · 56d
Cleared Aug 20, 2021
Altus Spine Sochi OCT Spinal System
K210887
Altus Partners, LLC
Orthopedic · 148d
Cleared Aug 18, 2021
QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments
K211957
Globus Medical, Inc.
Orthopedic · 55d
Cleared Aug 11, 2021
Z-LINKPC System
K211993
Zavation Medical Products, LLC
Orthopedic · 44d
Cleared Jul 30, 2021
Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems: (Firebird Deformity Spinal Fixation System, Phoenix MIS Spinal Fixation System, Phoenix CDX MIS Spinal Fixation System, JANUS Midline Fixation Screws, Firebird NXG Spinal Fixation System, JANUS Fenestrated Screws), Connector System, FIREBIRD SI Fusion System
K211710
Orthofix, Inc.
Orthopedic · 57d
Cleared Mar 18, 2021
Infinity™ OCT System, PASS OCT® Spinal System
K210449
Medtronic
Orthopedic · 30d
Cleared Feb 05, 2021
SYMPHONY™ OCT System
K203319
Medos International SARL
Orthopedic · 85d
Cleared Dec 18, 2020
Invictus™ OCT Spinal Fixation System
K203125
Alphatec Spine, Inc.
Orthopedic · 60d
Cleared Nov 16, 2020
M.U.S.T. MINI Posterior Cervical Screws System
K203149
Medacta International S.A.
Orthopedic · 25d
Cleared Oct 08, 2020
LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System
K200793
L & K Biomed Co., Ltd.
Orthopedic · 196d
Cleared Jun 15, 2020
Centurion POCT System
K201481
Orthofix, Inc.
Orthopedic · 11d
Cleared May 22, 2020
Invictus™ CT Spinal Fixation System
K200936
Alphatec Spine, Inc.
Orthopedic · 44d
Cleared May 01, 2020
PERLA® Posterior Occipito-Cervico-Thoracic Fixation System
K200571
Spineart
Orthopedic · 58d
Cleared Apr 28, 2020
Tiger® Occipital-Cervical-Thoracic Spinal Fixation System
K200863
Corelink, LLC
Orthopedic · 27d
Cleared Apr 28, 2020
Solstice CCI
K200896
Life Spine, Inc.
Orthopedic · 25d
Cleared Apr 07, 2020
VERTICALE® Cervical System
K192013
Silony Medical GmbH
Orthopedic · 253d
Cleared Apr 02, 2020
SYMPHONY™ OCT System
K192646
Medos International SARL
Orthopedic · 191d
Cleared Mar 25, 2020
NorthStar™ OCT Spinal System
K193615
SeaSpine Orthopedics Corporation
Orthopedic · 90d
Cleared Feb 10, 2020
M.U.S.T. MINI Posterior Cervical Screws System
K200130
Medacta International S.A.
Orthopedic · 20d