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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
Jan 19, 2021K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPS
Globus Medical, Inc.
NKB
Jan 15, 2021K203506PERLA® TL posterior osteosynthesis system
Spineart, CH
NKB
Jan 11, 2021K202505GetSet Surgical GoPLF! Posterior Lateral Fusion System
Getset Surgical, SA, CH
NKB
Dec 22, 2020K203452Nano FortiFix® System
Nanovis, LLC
NKB
Dec 17, 2020K203222PERLA TL Posterior Osteosynthesis System
Spineart, CH
NKB
Dec 17, 2020K203163ARx Illiac Spinal Screw System
Life Spine, Inc.
NKB
Dec 4, 2020K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal System
L&K BIOMED Co., Ltd., KR
NKB
Dec 3, 2020K203367LineSider™ Spinal System
Integrity Implants, Inc.
NKB
Nov 25, 2020K203317CarboClear X Pedicle Screw System
CarboFix Orthopedics , Ltd., IL
NKB
Nov 23, 2020K203056Invictus™ Spinal Fixation System
Alphatec Spine, Inc.
NKB
Nov 12, 2020K201568Calvary Spine Pedicle Screw System
Calvary Spine, LLC
NKB
Nov 5, 2020K202476Salvo® Spine System
Spine Wave, Inc.
NKB
Oct 28, 2020K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System
L&K BIOMED Co., Ltd., KR
NKB
Oct 26, 2020K202528Cannulated Power Driver Attachment
K2m, Inc.
NKB
Oct 26, 2020K200937ACURA Stabilization System
Indius Medical Technologies Pvt. , Ltd., IN
NKB
Oct 23, 2020K202894Wiltrom Spinal Fixation System
Wiltrom Corporation Limited, TW
NKB
Oct 21, 2020K201427Trivergent Spinal Fixation System
Benvenue Medical, Inc.
NKB
Oct 20, 2020K200794AccelFix Spinal Fixation System
L&K BIOMED Co., Ltd., KR
NKB
Oct 19, 2020K202771CD Horizon Spinal System
Medtronic
NKB
Oct 15, 2020K202327Invictus™ OsseoScrew® System
Alphatec Spine, Inc.
NKB
Oct 5, 2020K201659KHEIRON® Spinal Fixation System
S.M.A.I.O, FR
NKB
Sep 10, 2020K201407CD Horizon™ Spinal System
Medtronic Sofamor Danek USA, Inc.
NKB
Sep 8, 2020K202328CD Horizon Spinal System
Medtronic Sofamor Danek USA, Inc.
NKB
Aug 18, 2020K190600ORION Spinal System
Orion Biotech, Inc., TW
NKB
Aug 11, 2020K200981Mega Plus MIS Spine System
Bk Meditech, Co., Ltd., KR
NKB
Aug 7, 2020K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw System
CarboFix Orthopedics , Ltd., IL
NKB
Jul 30, 2020K201648Sterispine™ PS
Safe Orthopaedics, FR
NKB
Jul 22, 2020K201780True Tulip System, True M.I.S. System
Innovative Surgical Designs, Inc.
NKB
Jul 22, 2020K201751Pedicle Screw System
Black Box Medical, LLC
NKB
Jun 16, 2020K190408Spinal Fixation System
Shangdong Kangsheng Medical Devices Co., Ltd., CN
NKB
Jun 2, 2020K200322Altus Spine Pedicle Screw System
Altus Partners, LLC
NKB
May 22, 2020K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0
Icotec AG, CH
NKB
May 19, 2020K200303Reform Pedicle Screw System
Precision Spine
NKB
May 12, 2020K192930Dymaxeon Spine System
Back 2 Basics Direct, LLC
NKB
Apr 30, 2020K200519CarboClear® II Pedicle Screw System
CarboFix Orthopedics , Ltd., IL
NKB
Apr 24, 2020K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System
Medos International Sàrl, CH
NKB
Apr 23, 2020K200666Stryker Xia 3 Power Adaptor
Stryker Spine
NKB
Apr 23, 2020K200070ARx Spinal System
Life Spine, Inc.
NKB
Mar 24, 2020K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine System
OrthoPediatrics Corp.
NKB
Mar 20, 2020K193211Nano FortiFix® System
Nanovis Spine, LLC
NKB
Mar 6, 2020K200267LOSPA® IS™ Spinal Fixation System
Corentec Co., Ltd., KR
NKB
Mar 6, 2020K191655MEGAFIX® Pedicle Screw Spinal System
Seohancare Co., Ltd., KR
NKB
Feb 28, 2020K200381Daytona® Small Stature Spinal System
SeaSpine Orthopedics Corporation
NKB
Feb 13, 2020K193472OrthoCircle Spine Pedicle Screw System
Orthocircle Spine
NKB
Feb 5, 2020K193396PERLA® TL posterior osteosynthesis system
Spineart, CH
NKB
Jan 31, 2020K193270CapLOX II®/TowerLOX® MIS Pedicle Screw System
Captiva Spine, Inc.
NKB
Jan 27, 2020K193365M.U.S.T. Pedicle Screw System
Medacta International S.A., CH
NKB
Jan 15, 2020K190981NEX-D2 Posterior Fixation System
Next Orthosurgical
NKB
Jan 14, 2020K192800Streamline TL Spinal Fixation System
Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
NKB
Jan 10, 2020K193465CorticaLINK Spinal Fusion Platform
Spine Smith Holdings, LLC
NKB

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