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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 8, 2011K103040LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)
Lanx, LLC
NKB
Jan 18, 2011K103133VEPER SYSTEM, EXPEDIUM SYSTEM
Depuy Spine, Inc.
NKB
Jan 5, 2011K103287SYNTHES 6.0 COCR AND CPT TI-3 RODS
Synthes Spine
NKB
Dec 23, 2010K103049TSRH SPINAL SYSTEM
Medtronic Sofamor Danek
NKB
Dec 16, 2010K102249EXPEDIUM SPINE SYSTEM
Depuy Spine, A Johnson & Johnson Company
NKB
Dec 7, 2010K101993VIPER SYSTEM, EXPEDIUM SYSTEM
Depuy Spine, Inc.
NKB
Dec 1, 2010K102514NUVASIVE SPHERX II -MAS DEFORMITY SPINAL SYSTEM
Nuvasive, Inc.
NKB
Nov 17, 2010K102807CD HORIZON SPINAL SYSTEM
Medtronic Sofamor Danek, Inc.
NKB
Nov 17, 2010K102555CD HORIZON SPINAL SYSTEM
Medtronic Sofamor Danek USA, Inc.
NKB
Nov 15, 2010K102204CHOICE SPINE STARFIRE PEDICLE SCREW SYSTEM
Choicespine, LP
NKB
Oct 20, 2010K102701VIPER SPINE SYSTEM
Depuy Spine, Inc.
NKB
Oct 18, 2010K101933MODIFICATION TO:EXPEDIUM SPINE SYSTEM
Depuy Spine, Inc.
NKB
Oct 7, 2010K102248EXCELLA II SPINAL SYSTEM MODEL EC2-00
Innovasis, Inc.
NKB
Sep 30, 2010K101772TSRH(R) SPINAL SYSTEM
Medtronic Sofamor Danek
NKB
Sep 27, 2010K091445CD HORIZON SPINAL SYSTEM
Medtronic Sofamor Danek
NKB
Sep 21, 2010K100845PATHFINDER II, MINIMALLY INVASIE PEDICLE SCREW SYSTEM MODEL 3500 SERIES
Zimmer Spine, Inc.
NKB
Aug 31, 2010K101070EXPEDIUM SPINE SYSTEM
Medos International SARL
NKB
Aug 24, 2010K102235MANTIS SPINAL SYSTEM & MANTIS REDUX SPINAL SYSTEM
Stryker Spine
NKB
Aug 12, 2010K100970STAINLESS STEEL SPINAL SYSTEM
Theken Spine, LLC
NKB
Aug 11, 2010K093692QUANTUM/ STREAMLINE SPINAL SYSTEM MODEL 02-SERIES AND 10-SERIES
Pioneer Surgical Technology
NKB
Aug 6, 2010K100935LANX SPINAL FIXATION SYSTEM
Lanx, Inc.
NKB
Aug 5, 2010K100952MODIFICATION TO SYNTHES MATRIX SYSTEM
Synthes Spine
NKB
Jul 28, 2010K093926FIREBIRD SPINAL FIXATION SYSTEM
Blackstone Medical, Inc.
NKB
Jul 23, 2010K100147S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM
Aesculap Implant System, Inc.
NKB
Jul 8, 2010K101144MODIFICATION TO:RADIUS SPINAL SYSTEM
Stryker Spine
NKB
Jul 1, 2010K100757TILOCK PEDICLE SCREW SYSTEM
Genesys Spine
NKB
Jul 1, 2010K100634SYNTHES MATRIX SYSTEM
Synthes (Usa)
NKB
Jun 23, 2010K100438POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FIXATION SYSTEM
Ebi, L.P.
NKB
Jun 23, 2010K100409POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTUE ANTERIOR FIXATION SYSTEM
Biomet Spine (Aka Ebi, LLC)
NKB
Jun 22, 2010K101074MODIFICATION TO: CD HORIZON(R) SPINAL SYSTEM
Medtronic Sofamor Danek USA, Inc.
NKB
Jun 9, 2010K100623AESCULAP IMPLANT SYSTEMS S4 SPINAL SYSTEM
Aesculap Implant Systems
NKB
May 17, 2010K100220POLARIS SPINAL SYSTEM
Ebi, L.P.
NKB
May 14, 2010K100788COCR RODS
Globus Medical, Inc.
NKB
May 7, 2010K094002SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM
Spartek Medical, Inc.
NKB
Apr 30, 2010K091797TSRH SPINAL SYSTEM
Medtronic Sofamor Danek
NKB
Apr 12, 2010K100737MODIFICATION TO: TRIO+SPINAL FIXATION SYSTEM
Stryker Spine
NKB
Mar 9, 2010K093668SYNTHES MATRIX MIS RODS
Synthes (Usa)
NKB
Feb 17, 2010K093294REVERE STABILIZATION SYSTEM
Globus Medical, Inc.
NKB
Feb 4, 2010K100044FIREBIRD SPINAL FIXATION SYSTEM, FIREBIRD SIDE-LOADING BODY
Blackstone
NKB
Jan 25, 2010K091717ANY PLUS SPINAL FIXATION SYSTEM
GS Medical Co., Ltd.
NKB
Dec 29, 2009K092929SYNTHES MATRIX SYSTEM
Synthes (Usa)
NKB
Dec 15, 2009K092325MODIFICATION TO:CD HORIZON SPINAL SYSTEM
Medtronic Sofamor Danek USA, Inc.
NKB
Dec 3, 2009K092605XIA 4.5 SPINAL SYSTEM
Stryker Spine
NKB
Dec 2, 2009K093434VERTEX RECONSTRUCTION SYSTEM AND VERTEX SELECT RECONSTRUCTION SYSTEM
Medtronic Sofamor Danek
NKB
Nov 25, 2009K092473EXPEDIUM SPINE SYSTEM
Depuy Spine, Inc.
NKB
Nov 6, 2009K090605CLAMPFIX
Synthes (Usa)
NKB
Oct 30, 2009K092536SPINAL FIXATION SYSTEM
Lanx, Inc.
NKB
Oct 26, 2009K093058TSRH SPINAL SYSTEM
Medtronic Sofamor Danek, Inc.
NKB
Oct 6, 2009K092287NUVASIVE SPHERX II - PEDICLE SCREW SYSTEM
Nuvasive, Inc.
NKB
Oct 2, 2009K092676TSRH SPINAL SYSTEM
Medtronic Sofamor Danek, Inc.
NKB

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