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Panels › Orthopedic › Product code NKB · Class 2

Thoracolumbosacral Pedicle Screw System

Regulation 888.3070

33510(k)s in 12 months (914 all time)
4recalls in 12 months (182 all time)
177recalls that name a 510(k)
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Top companies in NKB

Company510(k)sRecalls
Medtronic Sofamor Danek982
Depuy Spine, Inc.3010
Nuvasive, Inc.931
Spinal Elements, Inc.1122
Stryker Spine225
Alphatec Spine, Inc.205
Zimmer Biomet, Inc.025
Globus Medical, Inc.240
Life Spine220
K2m200
Decided510(k)Device and applicantCode
Mar 23, 2016K160466Response 5.5 Spine System
OrthoPediatrics Corp.
NKB
Mar 8, 2016K153326Erisma-LP Spinal Fixation System
Clariance, Sas, FR
NKB
Feb 23, 2016K153323Palisade Pedicular Fixation System
Spineology, Inc.
NKB
Feb 18, 2016K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with the STEALTHSTATION System, Medtro
Medtronic Sofamor Danek USA, Inc.
NKB
Feb 12, 2016K152781Adena-Zina System
Shanghai Sanyou Medical Co, Ltd., CN
NKB
Feb 10, 2016K153589CD HORIZON Spinal System
Medtronic Sofamor Danek USA, Inc.
NKB
Jan 29, 2016K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System
Orthofix, Inc.
NKB
Jan 28, 2016K153525Seneka II Polyscrew Pedicle Fixation System
Senecka Spine
NKB
Jan 19, 2016K153664M.U.S.T. Pedicle Screw System
Medacta International, CH
NKB
Dec 30, 2015K153463CD HORIZON Spinal System, IPC POWEREASE System
Medtronic Sofamor Danek USA, Inc.
NKB
Dec 30, 2015K152968Arsenal Spinal Fixation System
Alphatec Spine, Inc.
NKB
Dec 2, 2015K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory
Stryker Corporation
NKB
Nov 20, 2015K151770Libra Pedicle Screw System
Spinal Balance, Inc.
NKB
Nov 17, 2015K153031RANGE/DENALI/MESA Spinal System
K2m, Incorporated
NKB
Nov 13, 2015K151974Polaris Spinal System
Biomet Spine
NKB
Nov 5, 2015K152248CD HORIZON Spinal System
Medtronic Sofamor Danek USA, Inc.
NKB
Oct 28, 2015K152039Genesys Spine TiLock2 Spinal System
Genesys Spine
NKB
Oct 27, 2015K152457CD HORIZON Spinal System
Medtronic Sofamor Danek USA, Inc.
NKB
Oct 16, 2015K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle Screw System, Valencia MIS Pedi
Altus Partners, LLC
NKB
Oct 8, 2015K151921STERISPINE PS
Safe Orthopaedics, FR
NKB
Oct 5, 2015K151747STERISPINE PS
Safe Orthopaedics, FR
NKB
Sep 30, 2015K151849Seneka I Polyscrew Pedicle Fixation System
Senecka Spine
NKB
Sep 17, 2015K151727Everest Spinal System
K2m, Inc.
NKB
Sep 4, 2015K151733Xenco Medical Pedicle Screw System
Xenco Medical, LLC
NKB
Sep 2, 2015K152148Fortress Pedicular Fixation System
Spineology, Inc.
NKB
Aug 31, 2015K150896Vitality Spinal Fixation System
Zimmer Spine, Inc.
NKB
Aug 21, 2015K151422Reform Pedicle Screw System
Precision Spine, Inc.
NKB
Aug 10, 2015K151216Everest Spinal System
K2m, Inc.
NKB
Jul 17, 2015K150380ProMIS Fixation System
Premia Spine, Ltd., IL
NKB
Jul 14, 2015K151196Nautilus Spinal System
Life Spine, Inc.
NKB
Jul 7, 2015K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System
Orthofix, Inc.
NKB
Jul 7, 2015K150856Reform Pedicle Screw System
Precision Spine, Inc.
NKB
Jun 24, 2015K143110GALAXY MIS Screw System
Bm Korea, KR
NKB
Jun 18, 2015K142752Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System, Nex-Link OCT Cervical Plating System
Zimmer Spine, Inc.
NKB
Jun 15, 2015K150184Dymaxeon Spine System
Back 2 Basics Direct, LLC
NKB
Jun 12, 2015K142835Iliad Pedicle Screw System and Zenius Pedicle Screw System
Medyssey USA, Inc.
NKB
Jun 3, 2015K151215Mercury Spinal System
Spinal Elements, Inc.
NKB
May 22, 2015K150600Response 5.5/6.0 Spine System
OrthoPediatrics Corp.
NKB
May 22, 2015K143683APEX-DL Spine System
Spinecraft, LLC
NKB
May 19, 2015K150417ASTRA SPINE SYSTEM
Spinecraft, LLC
NKB
May 12, 2015K150185Mont Blanc Spinal System
Spineway, FR
NKB
Apr 23, 2015K143684NuVasive Reline System
Nu Vasive, Incorporated
NKB
Apr 22, 2015K143363VENUS Spinal Fixation System
L&K BIOMED Co., Ltd., KR
NKB
Apr 14, 2015K143731IMPLANET Spine System (ISS)
Implanet, S.A., FR
NKB
Apr 8, 2015K143019CD HORIZON Spinal System, IPC POWEREASE System
Medtronic Sofamor Danek USA, Inc.
NKB
Apr 3, 2015K150507Santis Pedicle Screw System
Lanterna Medical Technologies, CH
NKB
Mar 31, 2015K150325Range/Denali/Mesa Spinal System
K2m, Inc.
NKB
Mar 20, 2015K142531F1-Modular Pedicle Screw System
Degen Medical
NKB
Mar 16, 2015K150390Nautilus Spinal System
Life Spine, Inc.
NKB
Feb 26, 2015K142576Spinal System
Eisertech, LLC
NKB

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