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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 25, 2014K140449CD HORIZON SPINAL SYSTEM
Medtronic Sofamor Danek, Inc.
NKB
Mar 21, 2014K133944RANGE, SPINAL SYSTEM, EVEREST SPINAL SYSTEM
K2m, Inc.
NKB
Mar 13, 2014K133221ARSENAL SPINAL FIXATION SYSTEM
Alphatec Spine, Inc.
NKB
Mar 12, 2014K133746POLARIS SPINAL SYSTEM
Biomet Spine (Aka Ebi, LLC)
NKB
Mar 11, 2014K133350REVERE STABILIZATION SYSTEM
Globus Medical, Inc.
NKB
Feb 19, 2014K133564MODIFICATION TO NAUTILUS SPINAL SYSTEM
Life Spine, LLC
NKB
Feb 11, 2014K132925SAVANNAH-T, REDUCTION, SAVANNAH-T, HIGH-TOP, SAVANNAH-T, MONOAXIAL MID-TOP, SAVANNAH-T, LOW-TOP, SAVANNAH-LINK
Amendia, Inc.
NKB
Jan 14, 2014K133369TIGER SPINE SYSTEM
Corelink, LLC
NKB
Jan 13, 2014K133066SPINESELECT POLYSCREW PEDICLE SCREW SYSTEM
Spineselect, LLC
NKB
Jan 13, 2014K133063SANTIS PEDICLE SCREW SYSTEM
Lanterna Medical Technologies
NKB
Dec 18, 2013K132878M.U.S.T. EXTENSION
Medacta International
NKB
Dec 17, 2013K133291ST360 DEGREES SPINAL FIXATION SYSTEM
Zimmer Spine, Inc.
NKB
Dec 17, 2013K133188MANTIS & MANTIS REDUX SPINAL SYSTEM, RADIUS SPINAL SYSTEM, TRIO & TRIO+ SPINAL FIXATION SYSTEMS, AND TRIO TRAUMA SPINAL
Stryker Spine
NKB
Dec 6, 2013K132328CD HORIZON SPINAL SYSTEM
Medtronic Sofamor Danek USA, Inc.
NKB
Nov 27, 2013K133086TITLE 2 POLYAXIAL SPINAL SYSTEM
Zimmer Spine, Inc.
NKB
Nov 25, 2013K132884PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
Zimmer Spine, Inc.
NKB
Nov 25, 2013K132639CD HORIZON SPINAL SYSTEM
Medtronic Sofamor Danek USA, Inc.
NKB
Nov 20, 2013K132603APEX SPINE SYSTEM
Spinecraft, LLC
NKB
Oct 31, 2013K132014GSB GLOBAL SPINAL BALANCE SYSTEM
Nuvasive, Inc.
NKB
Oct 28, 2013K132866NAUTILUS SPINAL SYSTEM
Life Spine, Inc.
NKB
Oct 8, 2013K132471CD HORIZON SPINAL SYSTEM
Medtronic Sofamor Danek USA, Inc.
NKB
Oct 3, 2013K132760NAUTILUS SPINAL SYSTEM
Life Spine, Inc.
NKB
Sep 10, 2013K131250TIGER SPINE SYSTEM
Corelink, LLC
NKB
Sep 4, 2013K131980SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM
Zimmer Spine, Inc.
NKB
Aug 23, 2013K131878LLIAD, KORA, ZENIUS PEDICLE SCREW SYSTEM
Medyssey USA, Inc.
NKB
Aug 20, 2013K131785PAGODA PEDICLE SCREW SYSTEM
Ortho Development Corp.
NKB
Aug 7, 2013K130932FIREBIRD SPINAL FIXATION SYSTEM
Orthofix, Inc.
NKB
Aug 6, 2013K132111CD HORIZON SPINAL SYSTEM
Medtronic Sofamor Danek USA
NKB
Jun 27, 2013K131100STREAMLINE TL SPINAL SYSTEM
Pioneer Surgical Technology, Inc.
NKB
Jun 20, 2013K130877EXPEDIUM SPINE SYSTEM
Medos International SARL
NKB
May 21, 2013K131119SOLANAS POSTERIOR STABILIZATION SYSTEM
Alphatec Spine, Inc.
NKB
May 3, 2013K130632STERISPINE PS PEDICLE SCREW
Safe Orthopaedics, FR
NKB
Apr 19, 2013K123552INSTINCT JAVA SYSTEM
Zimmer Spine
NKB
Apr 11, 2013K130291S4 SPINAL SYSTEM
Aesculap Implant System, Inc.
NKB
Apr 10, 2013K130646CD HORIZON SPINAL SYSTEM
Medtronic Sofamor Danek USA, Inc.
NKB
Apr 1, 2013K130286STREAMLINE MIS SPINAL FIXATION SYSTEM
Pioneer Surgical Technology, Inc.
NKB
Mar 28, 2013K130176FIREBIRD SPINAL FIXATION SYSTEM
Orthofix
NKB
Mar 12, 2013K123939S4 SPINAL SYSTEM
Aesculap Implant Systems, Inc.
NKB
Mar 6, 2013K123373NAUTILUS SPINAL SYSTEM
Life Spine
NKB
Mar 4, 2013K123717UCENTUM
Ulrich GmbH & Co. KG
NKB
Feb 25, 2013K123549POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM
Biomet Spine (Aka Ebi, LLC)
NKB
Feb 22, 2013K123809CD HORIZON SPINAL SYSTEM
Medtronic Sofamor Danek USA, Inc.
NKB
Feb 14, 2013K123623ILLICO MIS POSTERIOR FIXATION SYSTEM
Alphatec Spine, Inc.
NKB
Feb 1, 2013K123134EASYSPINE SYSTEM
Ldr Spine USA, Inc.
NKB
Jan 25, 2013K121670MEDYSSEY CANNULATED PEDICLE SCREW
Medyssey Co, Ltd.
NKB
Dec 12, 2012K123352S4 SPINAL SYSTEM
Aesculap Implant Systems, Inc.
NKB
Dec 12, 2012K122571MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM
Seaspine, Inc.
NKB
Dec 7, 2012K122845ES2 SPINAL SYSTEM MODEL 48280XXXX
Stryker Spine
NKB
Dec 3, 2012K123451POLARIS SPINAL SYSTEM - BALLISTA II RODS
Biomet Spine (Aka Ebi, LLC)
NKB
Dec 3, 2012K122901FIREBIRD SPINAL FIXATION SYSTEM, PHOENIX MIS SPINAL FIXATION SYSTEM
Orthofix
NKB

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