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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 9, 2017K170126NuVasive® Reline® 4.5-5.0 System
Nu Vasive, Incorporated
NKB
Mar 9, 2017K163604SeaSpine® Daytona® Small Stature Spinal System
SeaSpine Orthopedics Corporation
NKB
Feb 24, 2017K163056Revolution™ Spinal Fixation System
Intelligent Implant Systems, LLC
NKB
Feb 14, 2017K170163Erisma® LP Spinal Fixation System
Clariance, Sas, FR
NKB
Feb 9, 2017K163566Hubble I System
Orbbo Surgical, LLC
NKB
Feb 2, 2017K170061ProMIS™ Fixation System
Premia Spine, Ltd., IL
NKB
Jan 25, 2017K162786PASS LP Spinal System
Medicrea International SA, FR
NKB
Jan 23, 2017K161231Facilis™ Spinal System
Baui Biotech Co., Ltd., TW
NKB
Jan 19, 2017K162764JAZZ FRAME SYSTEM
Implanet, S.A., FR
NKB
Dec 20, 2016K163301CD HORIZON® Spinal System
Medtronic Sofamor Danek USA, Inc.
NKB
Dec 14, 2016K162134ENNOVATE Spinal System
Aesculap Implant Systems, LLC
NKB
Dec 8, 2016K162912VIPER PRIME™ additions to the VIPER® System
Medos International SARL, CH
NKB
Nov 18, 2016K162160Preference Elite Pedicle Screw System
Amedica Corporation
NKB
Nov 17, 2016K162232MOSS 100 Pedicle Screw System
Biedermann Motech GmbH & Co. KG, DE
NKB
Nov 16, 2016K162379CD HORIZON® Spinal System
Medtronic Sofamor Danek USA, Inc.
NKB
Nov 10, 2016K162576FORTEZZA Spinal Stabilization System
Osso Surgical
NKB
Oct 27, 2016K162750Libra Pedicle Screw System
Spinal Balance, Inc.
NKB
Oct 27, 2016K162367Erisma® LP MIS
Clariance, Sas, FR
NKB
Oct 21, 2016K162061M.U.S.T. Pedicle Screw System
Medacta International S.A., CH
NKB
Oct 13, 2016K161842Overwatch Spine System
Amendia, Inc.
NKB
Oct 4, 2016K162494CD HORIZON® Spinal System
Medtronic Sofamor Danek USA, Inc.
NKB
Sep 28, 2016K161014NuVasive® Reline® System
Nu Vasive, Incorporated
NKB
Sep 23, 2016K160640PASS XS Spinal System
Medicrea International SA, FR
NKB
Sep 8, 2016K161535SeaSpine® NewPort™ Spinal System
SeaSpine Orthopedics Corporation
NKB
Aug 25, 2016K161516G Surgical Marksman MIS System
G Surgical, LLC
NKB
Aug 22, 2016K161766PathLoc-L MIS Spinal System
L&K BIOMED Co., Ltd., KR
NKB
Aug 9, 2016K161914Genesys Spine TiLock Cortical Spinal System
Genesys Spine
NKB
Aug 4, 2016K161387Mont Blanc and Mont Blanc MIS Spinal Systems
Spineway SA, FR
NKB
Jul 29, 2016K161627PASS LP Spinal System
Medicrea International SA, FR
NKB
Jul 29, 2016K161499VertiForm Posterior Fixation System
Next Orthosurgical
NKB
Jul 21, 2016K161369EVEREST Spinal System
K2m, Incorporated
NKB
Jul 15, 2016K161694Threshold™ Pedicular Fixation System
Spineology, Inc.
NKB
Jul 8, 2016K152920Savannah-T® Pedicle Screw System
Amendia, Inc.
NKB
Jul 7, 2016K160722CorticaLINK Spinal Fusion Platform
Facetlink Dba Linkspine
NKB
Jul 1, 2016K160904Expedium Spine System, VIPER and VIPER 2 Systems
Medos International SARL, CH
NKB
Jun 28, 2016K160926F1 MPS Modular Pedicle Screw System
Degen Medical
NKB
Jun 28, 2016K160820PressON Pro Spinal Fixation System
Nexus Spine, LLC
NKB
Jun 10, 2016K161363Arsenal Spinal Fixation System
Alphatec Spine, Inc.
NKB
Jun 9, 2016K160989NuVasive® Reline® System
Nu Vasive, Incorporated
NKB
Jun 3, 2016K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems
Choicespine, LP
NKB
May 26, 2016K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation System
Spineology, Inc.
NKB
May 26, 2016K160902Mariner Pedicle Screw System
SeaSpine Orthopedics Corporation
NKB
May 18, 2016K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector
Implanet, S.A., FR
NKB
May 4, 2016K160986Xenco Medical Pedicle Screw System
Xenco Medical, LLC
NKB
Apr 27, 2016K153152Syzygy Stabilization System
Amendia, Inc.
NKB
Apr 26, 2016K153453Inertia Pedicle Screw and Deformity Correxxion System
Nexxt Spine, LLC
NKB
Apr 22, 2016K160216Revolution Spinal Fixation System
Intelligent Implant Systems, LLC
NKB
Apr 22, 2016K153413PASS LP Spinal System
Medicrea International SA, FR
NKB
Apr 13, 2016K151704Diplomat® Spinal System
Signus Medizintechnik GmbH, DE
NKB
Apr 12, 2016K151977icotec Pedicle System
Icotec AG, SE
NKB

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