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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 26, 2023K231737ANAX™ 5.5 Spinal System
Innosys Co., Ltd., KR
NKB
Oct 25, 2023K231069PERLA® TL Posterior Thoraco-lumbar Fixation System
Spineart SA, CH
NKB
Oct 24, 2023K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System
K&J Consulting Corp.
NKB
Oct 23, 2023K232561Ripley Spinal Screw System by SAGICO
Sagico VA USA, LLC
NKB
Oct 13, 2023K231744VyLink™ Spinal Screw System
Vy Spine, LLC
NKB
Oct 11, 2023K230116Vital™ Spinal Fixation System
Zimvie Spine (Zimmer Biomet Spine, Inc.)
NKB
Oct 10, 2023K232341CarboClear® Pedicle Screw System
CarboFix Orthopedics , Ltd., IL
NKB
Oct 10, 2023K231658VEOS Spinal Fixation System
Spineway, FR
NKB
Oct 10, 2023K230961Zeus Spinal System
Shanghai Sanyou Medical Co, Ltd., CN
NKB
Sep 29, 2023K232650KHEIRON® Spinal Fixation System, including patient specific K-ROD
S.M.A.I.O, FR
NKB
Sep 27, 2023K232275Invictus® Spinal Fixation System
Alphatec Spine, Inc.
NKB
Sep 22, 2023K231479TriALTIS Spine System
Medos International SARL, CH
NKB
Sep 15, 2023K230974NIDO™ Pedicle Screw System
Kalitec Medical
NKB
Aug 24, 2023K232218Zenius™ Spinal System
Medyssey USA, Inc.
NKB
Aug 22, 2023K231811Zavation Connector System
Zavation Medical Products, LLC
NKB
Aug 16, 2023K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System (Modular Extended Tab Head)
Medtronic Sofamor Danek USA, Inc.
NKB
Aug 14, 2023K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System
L&K BIOMED Co., Ltd., KR
NKB
Aug 7, 2023K231098LineSider® Spinal System
Integrity Implants, Inc.
NKB
Jul 28, 2023K231931Adena-Zina Spinal System
Shanghai Sanyou Medical Co, Ltd., CN
NKB
Jul 20, 2023K231799INERTIA® CONNEXX™ Modular Pedicle Screw System
Nexxt Spine, LLC
NKB
Jul 7, 2023K231844ProMIS™ Fixation System
Premia Spine, Ltd., IL
NKB
Jul 6, 2023K223806VERTICALE® Triangular Fixation System
Silony Medical GmbH, DE
NKB
Jul 3, 2023K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X Fenestrated Pedicle Screw System
CarboFix Orthopedics , Ltd., IL
NKB
Jun 27, 2023K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.
L&K BIOMED Co., Ltd., KR
NKB
Jun 15, 2023K230762EDEN Spinal Fixation MIS System
Jmt Co., Ltd., KR
NKB
Jun 8, 2023K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conv
Stryker Spine
NKB
May 26, 2023K223096Dark Star Deformity Pedicle Screw System
Republic Spine, LLC
NKB
May 25, 2023K222229Advanced LumFix Spinal Fixation System
CG Bio Co., Ltd., KR
NKB
May 2, 2023K223529PressON Spinal Fixation System
Nexus Spine, LLC
NKB
Apr 20, 2023K212220ArtFX Spinal Fixation System
Artfx Medical, LLC
NKB
Apr 19, 2023K230766Altus Spine Monaco Pedicle Screw System
Altus Spine
NKB
Mar 23, 2023K230482Swedge™ Pedicle Screw Fixation System
Spinal Resources, Inc.
NKB
Mar 23, 2023K222105RESPONSE 5.5/6.0 Cannulated Screw System
OrthoPediatrics Corp.
NKB
Feb 28, 2023K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation System
L&K BIOMED Co., Ltd., KR
NKB
Feb 9, 2023K230063G Surgical Marksman Spinal Deformity System
G Surgical, LLC
NKB
Jan 23, 2023K223494CD Horizon Spinal System
Medtronic
NKB
Jan 11, 2023K223181NuVasive Reline System
Nu Vasive, Incorporated
NKB
Dec 23, 2022K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.
L&K BIOMED Co., Ltd., KR
NKB
Dec 22, 2022K223273ASTRA Spine System
Spinecraft, LLC
NKB
Dec 5, 2022K222614Zavation Spinal System
Zavation Medical Products, LLC
NKB
Dec 1, 2022K222516Mercury® II Spinal System
Spinal Elements, Inc.
NKB
Nov 28, 2022K223274Momentum® MIS Posterior Spinal Fixation System
Ulrich Medical USA
NKB
Nov 15, 2022K212700Dyflex-II
Taeyeon Medical Co., Ltd., KR
NKB
Oct 28, 2022K222031Spinal Inner Fixation System
Changzhou Geasure Medical Apparatus and Instruments Co., Ltd., CN
NKB
Oct 25, 2022K222415Rexious Spinal Fixation System
Dio Medical Corporation
NKB
Oct 13, 2022K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods
Medos-International Sarl, CH
NKB
Oct 4, 2022K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™ SPINAL SYSTEM; CD Horizon™ Fenestr
Medtronic Sofamor Danek USA, Inc.
NKB
Sep 16, 2022K220297True Tulip, True M.I.S.
Innovative Surgical Designs, Inc.
NKB
Sep 16, 2022K211027Altus Spine Pedicle Screw System
Altus Partners, LLC
NKB
Sep 7, 2022K222110Mariner RDX System
SeaSpine Orthopedics Corporation
NKB

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