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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
Feb 25, 2015K143230Palladian Lumbar Pedicle Screw System
Neurostructures, Inc.
NKB
Feb 13, 2015K143375CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments
Medtronic Sofamor Danek USA, Inc.
NKB
Feb 12, 2015K143569CD HORIZON Spinal System
Medtronic Sofamor Danek USA, Inc.
NKB
Feb 12, 2015K141222NAUTILUS SPINAL SYSTEM AND SOLSTICE OCT SYSTEM
Life Spine, Inc.
NKB
Feb 11, 2015K150178CD HORIZON SPINAL SYSTEM
Medtronic Sofamor Danek USA, Inc.
NKB
Feb 10, 2015K150092STERISPINE PS Pedicle Screw
Safe Orthopaedics, FR
NKB
Feb 3, 2015K143200MIS Z-Pedicle Screw System
Z-Medical GmbH & Co. KG, DE
NKB
Jan 30, 2015K143633CREO Stabilization System
Globus Medical, Inc.
NKB
Jan 21, 2015K142360Everest Spinal System
K2m, Inc.
NKB
Jan 13, 2015K142939Revolution Spinal Fixation System
Intelligent Implant Systems, LLC
NKB
Jan 9, 2015K143334Range/Denali/Mesa Spinal System
K2m, Inc.
NKB
Jan 9, 2015K141398PASS LP SPINAL SYSTEM
Medicrea International SA, FR
NKB
Jan 5, 2015K143149Arsenal Spinal Fixation System
Alphatec Spine, Inc.
NKB
Jan 2, 2015K141186FIREBIRD SPINAL FIXATION SYSTEM
Orthofix, Inc.
NKB
Dec 30, 2014K141695ACROSSPINE PEDICLE SCREW SYSTEM
Arthro-Dif
NKB
Dec 19, 2014K143248Reform Pedicle Screw System
Precision Spine, Inc.
NKB
Dec 18, 2014K143403Threshold Pedicular Fixation System
Spineology, Inc.
NKB
Dec 18, 2014K142737MAS PLIF Fixation system
Nu Vasive, Incorporated
NKB
Dec 11, 2014K142146IBIS PEDICLE SCREW SYSTEM
Ortho Development Corp.
NKB
Dec 2, 2014K141282PGS 5.5 MM CANNULATED PEDICLE SCREW
Pinnacle Spine Group
NKB
Dec 1, 2014K143141CD HORIZON Spinal System
Medtronic Sofamor Danek USA, Inc.
NKB
Dec 1, 2014K142591CD HORIZON Spinal System
Medtronic Sofamor Danek USA, Inc.
NKB
Nov 19, 2014K142499Reline System
Nu Vasive, Incorporated
NKB
Nov 19, 2014K142185EXPEDIUM VERSE SPINE SYSTEM
Depuy Spine, Inc.
NKB
Oct 27, 2014K142847CD HORIZON Spinal System
Medtronic Sofamor Danck USA, Inc.
NKB
Oct 27, 2014K141850FLOSPINE PEDICLE SCREW SYSTEM
Flospine
NKB
Oct 21, 2014K142381Xia 3 Spinal System
Stryker Corp.
NKB
Oct 21, 2014K141604CD HORIZON SPINAL SYSTEM
Medtronic Sofamor Danek USA, Inc.
NKB
Sep 25, 2014K141804POLARIS SPINAL SYSTEM - HA COATED
Biomet Spine, LLC
NKB
Sep 8, 2014K141873RANGE/MESA/DENALI SPINAL SYSTEM
K2m, Inc.
NKB
Aug 26, 2014K141291VERTIFORM POSTERIOR FIXATION SYSTEM
Next Orthosurgical
NKB
Aug 22, 2014K141372MERCURY SPINAL SYSTEM
Spinal Elements, Inc.
NKB
Aug 19, 2014K141988M.U.S.T PEDICLE SCREW SYSTEM
Medacta International
NKB
Aug 18, 2014K141044M.U.S.T. EXTENSION
Medacta International
NKB
Aug 15, 2014K132049THUNDERBOLT AND LANCER PEDICLE SCREW SYSTEMS
Choicespine
NKB
Aug 6, 2014K141494CD HORIZON SPINAL SYSTEM
Medtronic Sofamor Danek USA, Inc.
NKB
Jul 30, 2014K133402K2M MODULAR HOOKS
K2m, Inc.
NKB
Jul 14, 2014K141605CD HORIZON SPINAL SYSTEM
Medtronic Sofamor Danek USA, Inc.
NKB
Jul 10, 2014K140765RANGE/MESA/DENALI SPINAL SYSTEM
K2m, Inc.
NKB
Jun 4, 2014K140802STERISPINE PS
Safe Orthopaedics, FR
NKB
Jun 3, 2014K141147RANGE SPINAL SYSTEM
K2m, Inc.
NKB
May 22, 2014K140529EVEREST SPINAL SYSTEM
K2m, LLC
NKB
May 7, 2014K140238EXCELLA III-D SPINAL DEFORMITY SYSTEM
Innovasis, Inc.
NKB
Apr 24, 2014K140123POLARIS SPINAL SYSTEM -TRANSLATION SCREW
Ebi, LLC
NKB
Apr 23, 2014K140010FORTRESS PEDICLE SCREW SYSTEM
Spineology, Inc.
NKB
Apr 14, 2014K140219PICASSO II MIS SPINAL SYSTEM
Accel Spine
NKB
Apr 10, 2014K140696STREAMLINE TL SPINAL FIXATION SYSTEM
Pioneer Surgical Technology, Inc.
NKB
Apr 8, 2014K133366ORTHROS POSTERIOR STABILIZATION SYSTEM
Camber Spine
NKB
Apr 7, 2014K133743BAXANO SURGICAL MIS SPINAL SYSTEM
Baxano Surgical, Inc.
NKB
Mar 25, 2014K140457NAUTILUS SPINAL SYSTEM
Life Spine, Inc.
NKB

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