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Panels › Orthopedic › Product code NKG · Class 2

Posterior Cervical Screw System

Regulation 888.3075

5510(k)s in 12 months (119 all time)
0recalls in 12 months (6 all time)
6recalls that name a 510(k)
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Top companies in NKG

Company510(k)sRecalls
Orthofix, Inc.72
K2m53
Medtronic Sofamor Danek USA, Inc.70
Medacta International S.A.60
Medos International SARL60
Nu Vasive, Incorporated60
Medicrea International50
Globus Medical, Inc.40
L&K BIOMED Co., Ltd.40
Life Spine, Inc.40
Decided510(k)Device and applicantCode
Sep 17, 2026K254260The VEGA Cervical Screw System
GS Medical Co., Ltd., KR
NKG
Jun 2, 2026K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems
ZheJiang Decans Medical Devices Co., Ltd., CN
NKG
Mar 16, 2026K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System
CarboFix Orthopedics , Ltd., IL
NKG
Jan 21, 2026K254165Infinity™ OCT System
Medtronic Sofamor Danek USA, Inc.
NKG
Nov 12, 2025K252327CMORE® CT System; CMORE® CT System Navigated Instruments
Icotec AG, CH
NKG
Oct 24, 2025K253129Infinity™ OCT System
Medtronic Sofamor Danek USA, Inc.
NKG
Jun 25, 2025K251725ANAX™ OCT Spinal System
Cg Medtech Co., Ltd., KR
NKG
May 20, 2025K250866Sovereign Posterior Cervical System
Met One Technologies, LLC
NKG
May 13, 2025K242674Freedom Posterior Cervical Screws
Signature Orthopaedics Pty, Ltd., AU
NKG
Apr 4, 2025K250332Virage® OCT Spinal Fixation System
Highridge Medical, LLC
NKG
Nov 19, 2024K242516EUROPA™ Posterior Cervical Fusion System
MiRus, LLC
NKG
Mar 27, 2024K233989CarboClear® Posterior Cervical Screw System
CarboFix Orthopedics , Ltd., IL
NKG
Mar 14, 2024K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments
Globus Medical, Inc.
NKG
Nov 27, 2023K233332Statera-C™ Spinal System
K&J Consulting Corp.
NKG
Nov 22, 2023K233078Posterior Cervical Spine System
Double Medical Technology, Inc., CN
NKG
Nov 9, 2023K233366SYMPHONY OCT System
Medos International SARL, CH
NKG
Sep 27, 2023K232167VySpan™ PCT System
Vy Spine, LLC
NKG
Aug 3, 2023K231654NorthStar OCT System
Seaspine, Inc.
NKG
Jul 20, 2023K231840CastleLoc-S Posterior Cervical Fixation System
L&K BIOMED Co., Ltd., KR
NKG
Jul 10, 2023K221307Edge Upper Cervical System
Spinal Simplicity, LLC
NKG
May 2, 2023K230614Cortium™
Ulrich Medical USA
NKG
Feb 24, 2023K223852VySpan™ PCT System
Vy Spine, LLC
NKG
Jan 11, 2023K223764INFINITY OCT System
Medtronic Sofamor Danek USA, Inc.
NKG
Nov 18, 2022K220658COSY Cervicothoracic Occipital Rod-Screw System
Signus Medizintechnik GmbH, DE
NKG
Nov 3, 2022K222107Black Diamond™ POCT Spinal System
Osseus Fusion Systems
NKG
Sep 9, 2022K221388NuVasive Reline Cervical System
Nu Vasive, Incorporated
NKG
Jul 1, 2022K213871Ennovate Cervical Spinal and Occiput System
Aesculap Implant Systems, LLC
NKG
Apr 26, 2022K220570M.U.S.T. MINI Posterior Cervical Screws System Extension
Medacta International S.A., CH
NKG
Apr 19, 2022K220810Infinity™ OCT System and PASS OCT Spinal System
Medicrea International, FR
NKG
Feb 23, 2022K213654NuVasive Reline Cervical System
Nu Vasive, Incorporated
NKG
Dec 10, 2021K213394Vy Spine™ VySpan™ PCT System
Vy Spine, LLC
NKG
Aug 20, 2021K210887Altus Spine Sochi OCT Spinal System
Altus Partners, LLC
NKG
Aug 18, 2021K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments
Globus Medical, Inc.
NKG
Aug 11, 2021K211993Z-LINKPC System
Zavation Medical Products, LLC
NKG
Jul 30, 2021K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems: (Firebird Def
Orthofix, Inc.
NKG
Mar 18, 2021K210449Infinity™ OCT System, PASS OCT® Spinal System
Medtronic
NKG
Feb 5, 2021K203319SYMPHONY™ OCT System
Medos International SARL, CH
NKG
Dec 18, 2020K203125Invictus™ OCT Spinal Fixation System
Alphatec Spine, Inc.
NKG
Nov 16, 2020K203149M.U.S.T. MINI Posterior Cervical Screws System
Medacta International S.A., CH
NKG
Oct 8, 2020K200793LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System
L&K BIOMED Co., Ltd., KR
NKG
Jun 15, 2020K201481Centurion POCT System
Orthofix, Inc.
NKG
May 22, 2020K200936Invictus™ CT Spinal Fixation System
Alphatec Spine, Inc.
NKG
May 1, 2020K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation System
Spineart, CH
NKG
Apr 28, 2020K200896Solstice CCI
Life Spine, Inc.
NKG
Apr 28, 2020K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation System
Corelink, LLC
NKG
Apr 7, 2020K192013VERTICALE® Cervical System
Silony Medical GmbH, DE
NKG
Apr 2, 2020K192646SYMPHONY™ OCT System
Medos International SARL, CH
NKG
Mar 25, 2020K193615NorthStar™ OCT Spinal System
SeaSpine Orthopedics Corporation
NKG
Feb 10, 2020K200130M.U.S.T. MINI Posterior Cervical Screws System
Medacta International S.A., CH
NKG
Feb 7, 2020K193129Yukon OCT Spinal System
K2m, Inc.
NKG

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