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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
Oct 18, 2018K182239OLYMPIC Posterior Spinal Fixation System
Astura Medical, LLC
NKB
Oct 17, 2018K182240PASS LP Spinal System
Medicrea International SA, FR
NKB
Oct 10, 2018K172826Cellent Spinal Systems
Jiangsu Trauhui Medical Instrument Co., Ltd., CN
NKB
Oct 4, 2018K182059Prase MIS Spinal System
Gbs Commonwealth Co., Ltd., KR
NKB
Sep 27, 2018K182377CarboClear® Pedicle Screw System
CarboFix Orthopedics , Ltd., IL
NKB
Sep 25, 2018K181980OsseoScrew System
Alphatec Spine, Inc.
NKB
Sep 20, 2018K181995Chiral Surgical Pedicle Screw System
Chiral Surgical
NKB
Sep 18, 2018K181390Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System
OrthoPediatrics Corp.
NKB
Sep 13, 2018K181821MOSS VRS Spinal System
Biedermann Motech GmbH & Co. KG, DE
NKB
Aug 29, 2018K182119CD HORIZON™ Spinal System
Medtronic Sofamor Danek USA, Inc.
NKB
Aug 24, 2018K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird® NXG Spinal Fixation System; Pho
Orthofix, Inc.
NKB
Aug 13, 2018K181978Zenius™, Iliad™ and Kora™ Spinal Fixation Systems
Medyssey USA, Inc.
NKB
Aug 10, 2018K181584Redi-Spine
Innovative Surgical Designs, Inc.
NKB
Aug 9, 2018K181677Kodiak Spinal Fixation System
Alphatec Spine, Inc.
NKB
Jul 27, 2018K181554Stowe Pedicle Screw System
Black Box Medical
NKB
Jul 25, 2018K181495Republic Spine Dark Star Spinal System
Republic Spine, LLC
NKB
Jul 25, 2018K180226TREND II Spinal Fixation System- STEP Series
Paonan Biotech Co., Ltd., TW
NKB
Jul 24, 2018K181339Altus Spine Pedicle Screw System
Altus Partners, LLC
NKB
Jul 23, 2018K173645JASPER Spinal Fixation System
Gbs Commonwealth Co., Ltd., KR
NKB
Jul 18, 2018K173487CarboClear® Pedicle Screw System
CarboFix Orthopedics , Ltd., IL
NKB
Jul 13, 2018K180655Viking Lumbar Polyaxial Screw System
Presidio Surgical
NKB
Jul 6, 2018K181139OLYMPIC Posterior Spinal Fixation System
Astura Medical, LLC
NKB
Jun 26, 2018K181119Range (Denali and Mesa) Spinal Systems
K2m, Inc.
NKB
Jun 11, 2018K181281Altus Spine Pedicle Screw System
Altus Partners, LLC
NKB
May 30, 2018K181188EVEREST Spinal System
K2m, Inc.
NKB
May 21, 2018K180220SAGICO OSI Spinal System by Osimplant
Spinal Analytics & Geometrical Implant Co, LLC
NKB
May 14, 2018K180686SeaSpine Daytona Small Stature Spinal System
SeaSpine Orthopedics Corporation
NKB
Apr 26, 2018K180433ENNOVATE®
Aesculap Implant Systems, LLC
NKB
Apr 17, 2018K180458FOCUS Pedicle Screw System
Nvision Biomedical Technologies, LLC
NKB
Apr 10, 2018K180301AXIS 5.5 Lumbar Pedicle Screw System
Axis Orthopaedics
NKB
Apr 10, 2018K172967Mercury® Spinal System
Spinal Elements, Inc.
NKB
Apr 6, 2018K180324Patriot Spinal Fixation System
Valorus Spine
NKB
Apr 5, 2018K180376K2M Patient Specific Rods
K2m, Inc.
NKB
Apr 2, 2018K180210CREO® Stabilization System
Globus Medical, Inc.
NKB
Mar 19, 2018K180475CapLOX II® / TowerLOX® MIS Pedicle Screw System
Captiva Spine, Inc.
NKB
Mar 15, 2018K180153X-spine Cortical Bone Screw System
X-Spine Systems, Inc.
NKB
Mar 15, 2018K173180Mega Plus Spine System
Bk Meditech, Co., Ltd., KR
NKB
Mar 8, 2018K173249CD HORIZON™ Spinal System
Medtronic Sofamor Danek USA, Inc.
NKB
Mar 6, 2018K172267IRENE Thoracolumbar Fixation System
Tianjin Zhengtian Medical Instrument Co., Ltd., CN
NKB
Feb 20, 2018K180176SeaSpine NewPort Spinal System
SeaSpine Orthopedics Corporation
NKB
Feb 14, 2018K173185SEURAT™ Universal Pedicle Screw System
Ctl Medical Corporation
NKB
Feb 6, 2018K173882SeaSpine Mariner Pedicle Screw System
SeaSpine Orthopedics Corporation
NKB
Jan 29, 2018K173814DeGen Medical E3 MIS Pedicle Screw System
Degen Medical
NKB
Jan 12, 2018K172548Wiltrom Spinal Fixation System
Wiltrom Corporation Limited, TW
NKB
Jan 10, 2018K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® System
Silony Medical GmbH, DE
NKB
Jan 9, 2018K173508Everest Spinal System
K2m
NKB
Dec 19, 2017K173130Reform® Midline Cortical Screw System
Precision Spine, Inc.
NKB
Dec 13, 2017K173524ANAX 5.5™ Spinal System
U&I Corporation, KR
NKB
Dec 11, 2017K173484CorticaLINK Spinal Fusion Platform
Linkspine, Inc.
NKB
Dec 8, 2017K173131Rexious Spinal Fixation System
Huvexel Co. , Ltd., KR
NKB

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