ClearanceBrief
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)
Get daily alerts for NKBSample briefCSV

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 10, 2020K193011CD Horizon™ Fenestrated Screw Set
Medtronic Sofamor Danek USA, Inc.
NKB
Dec 18, 2019K192680Percusys® Plus Pedicle Screw System
Joimax GmbH, DE
NKB
Dec 17, 2019K193219G Surgical Marksman System
G Surgical, LLC
NKB
Dec 12, 2019K192938Invictus™ Spinal Fixation System
Alphatec Spine, Inc.
NKB
Nov 26, 2019K192396Streamline MIS Spinal Fixation System
Pioneer Surgical Technology, Inc.
NKB
Nov 13, 2019K192915GMA 2.0 Pedicle Screw System
Grafton Medical Alliance
NKB
Oct 29, 2019K192121Black Diamond Pedicle Screw System
Osseus Fusion Systems
NKB
Oct 22, 2019K192268Europa Pedicle Screw System
MiRus, LLC
NKB
Oct 19, 2019K190636NuVasive® Reline® 4.5-5.0 System
Nu Vasive, Incorporated
NKB
Oct 2, 2019K191932Momentum™ Posterior Spinal Fixation System
Ulrich Medical USA
NKB
Sep 16, 2019K191576Mercury® Spinal System, Overwatch® Spinal System
Spinal Elements, Inc.
NKB
Sep 12, 2019K191726mont blanc & mont blanc MIS Spinal Systems
Spineway SA, FR
NKB
Aug 28, 2019K191810Curiteva Pedicle Screw System
Curiteva, Inc.
NKB
Aug 12, 2019K191494Facilis™ Spinal System
Baui Biotech Co., Ltd., TW
NKB
Aug 8, 2019K191575ARx Spinal System
Life Spine, Inc.
NKB
Aug 6, 2019K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS Instruments
Globus Medical, Inc.
NKB
Aug 2, 2019K183091Elaris Pedicle Screw System
Spinewelding AG, CH
NKB
Jul 24, 2019K1904714CIS® Chiron Spinal Fixation System
Solco Biomedical Co., Ltd., KR
NKB
Jul 19, 2019K191757EUROPA Pedicle Screw System
MiRus, LLC
NKB
Jul 19, 2019K191648Mariner MIS Pedicle Screw System; SeaSpine Navigation System
SeaSpine Orthopedics Corporation
NKB
Jul 10, 2019K191045Salvo™ Spine System
Spine Wave, Inc.
NKB
Jun 21, 2019K190360LineSider™ Spinal System
Integrity Implants, Inc.
NKB
Jun 20, 2019K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0
Icotec AG, CH
NKB
Jun 19, 2019K190762The JASPER Spinal Fixation System II
Gbs Commonwealth Co., Ltd., KR
NKB
Jun 11, 2019K182416NOVA Minimally Invasive System
Baui Biotech Co., Ltd., TW
NKB
May 28, 2019K182544AccelFix Spinal Fixation System
L&K BIOMED Co., Ltd., KR
NKB
May 23, 2019K183639Mariner Outrigger Revision System
SeaSpine Orthopedics Corporation
NKB
May 8, 2019K190567KeYi Spinal Fixation System
Beijing Keyi Medical Device Technology Co., Ltd., CN
NKB
May 2, 2019K190376PASS LP Spinal System
Medicrea International SA, FR
NKB
Apr 11, 2019K190317Zavation Spinal System
Zavation Medical Products, LLC
NKB
Apr 8, 2019K183550Vitality® Spinal Fixation System
Zimmer Biomet Spine, Inc.
NKB
Apr 8, 2019K182375CREO® Stabilization System, Navigation Instruments, ExcelsiusGPS®
Globus Medical, Inc.
NKB
Mar 18, 2019K190361Zavation Spinal System
Zavation Medical Products, LLC
NKB
Mar 14, 2019K180337EUROPA Pedicle Screw System
MiRus, LLC
NKB
Mar 13, 2019K183430Modular Spinal Fixation System
Life Spine, Inc.
NKB
Mar 12, 2019K182771ISS-JAZZ Screw System and JAZZ CAP SP
Implanet, S.A., FR
NKB
Feb 13, 2019K182974NuVasive Reline System
Nu Vasive, Incorporated
NKB
Feb 1, 2019K180626Pedimax II - Pedicular Screw Spinal System
Gm Dos Reis Industria E Comerico Ltda., BR
NKB
Jan 22, 2019K182970EUROPA™ Pedicle Screw System
MiRus, LLC
NKB
Jan 15, 2019K182478Whistler Modular Pedicle Screw System
Evolution Spine, LLC
NKB
Dec 13, 2018K181824CBT Screw Fixation System
U&I Corporation, KR
NKB
Dec 12, 2018K182954Salvo™ Spine System
Spine Wave, Inc.
NKB
Dec 12, 2018K182339LEUCADIA AUTOLOK™ Pedicle Screw System
Clearview Orthopedic Development, LLC
NKB
Dec 11, 2018K183168OpenLoc-L Spinal Fixation System
L&K BIOMED Co., Ltd., KR
NKB
Dec 10, 2018K183080Mega Plus Spine System
Bk Meditech, Co., Ltd., KR
NKB
Dec 7, 2018K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw System
Signature Orthopaedics Pty, Ltd., AU
NKB
Nov 15, 2018K183117PathLoc-L MIS Spinal System
L&K BIOMED Co., Ltd., KR
NKB
Nov 13, 2018K182598VersaLink™ Fixation System
Premia Spine, Ltd.
NKB
Oct 27, 2018K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System
Camber Spine Technologies, LLC
NKB
Oct 23, 2018K182283FUSE Pedicle Screw System
Black Box Medical
NKB

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.