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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
Nov 20, 2012K122229VICEROY SPINAL SYSTEM
Torrey Spine
NKB
Nov 16, 2012K123246CD HORIZON SPIRE Z SPINAL SYSTEM
Medtronic Sofamor Danek
NKB
Nov 5, 2012K121786DYMAXEON SPINE SYSTEM
B2b Spine Pty, Ltd.
NKB
Oct 5, 2012K121728TIGER SPINE SYSTEM
Corelink, LLC
NKB
Oct 3, 2012K122862CD HORIZON SPINAL SYSTEM
Medtronic Sofamor Danek USA, Inc.
NKB
Oct 1, 2012K122226REVERE STABILIZATION SYSTEM
Globus Medical, Inc.
NKB
Oct 1, 2012K120891TANGORS MULTIFUNCTIONAL POSTERIOR SYSTEM
Ulrich GmbH & Co. KG
NKB
Sep 28, 2012K122433CD HORIZON SPINAL SYSTEM
Medtronic Sofamor Danek, Inc.
NKB
Sep 21, 2012K121568DALI SPINAL FIXATION SYSTEM
Accel Spine
NKB
Sep 11, 2012K122352NUVASIVE PRECEPT SPINAL SYSTEM
Nuvasive, Inc.
NKB
Sep 10, 2012K121316LANX SPINAL FIZATION SYSTEM
Lanx, Inc.
NKB
Aug 28, 2012K113666XIA 3 SPINAL SYSTEM
Stryker Spine
NKB
Aug 24, 2012K121619NUVASIVE POLYAXIAL SPINAL SCREWS
Nuvasive, Inc.
NKB
Aug 24, 2012K121103LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASYSPINE, POSTERIOR SPINAL SYSTEM, LDR SPINE USA MC IMPLANT S
Ldr Spine USA, Inc.
NKB
Aug 21, 2012K121764CD HORIZON SPINAL SYSTEM
Medtronic Sofamor Danek, Inc.
NKB
Aug 17, 2012K122145LANX SPINAL FIXATION SYSTEM
Lanx, Inc.
NKB
Aug 13, 2012K120469ERISMA-LP
Clariance
NKB
Aug 9, 2012K120714PICASSO MIS SPINAL FIXATION SYSTEM
Accel Spine
NKB
Aug 7, 2012K111953NAUTILUS SPINAL SYSTEM
Life Spine
NKB
Aug 2, 2012K121940LANX SPINAL FIXATION SYSTEM
Lanx, Inc.
NKB
Jul 31, 2012K120838SYNTHES MATRIX SYSTEM
Synthes Spine
NKB
Jul 30, 2012K121299STERISPINEPS PEDICLE SCREW, STERISPINEPS ROD
Safe Orthopaedics, FR
NKB
Jul 30, 2012K120467SPINAL ELEMENTS POSTERIOR CERVICAL/THORACIC SPINAL SYSTEM
Spinal Elements, Inc.
NKB
Jul 26, 2012K121922BEACON STABILIZATION SYSTEM
Globus Medical, Inc.
NKB
Jul 18, 2012K121671PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
Zimmer Spine, Inc.
NKB
Jul 16, 2012K120564CALYPSO SYSTEM
Hogan Lovells US LLP
NKB
Jul 5, 2012K121680CD HORIZON SPINAL SYSTEM
Medtronic Sofamor Danek USA, Inc.
NKB
Jun 22, 2012K121342XIA 4.5 SPINAL SYSTEM
Stryker Corp.
NKB
Jun 15, 2012K121130POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODS
Biomet Spine
NKB
Jun 14, 2012K113395REVERE 4.5 STABILIZATION SYSTEM
Globus Medical, Inc.
NKB
Jun 14, 2012K111136EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM
Depuy Spine, Inc.
NKB
Jun 7, 2012K112607SPINEVISION LUMIS(TM) CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S.(TM) POLYAXIAL PEDICLE ...
Spinevision S.A.
NKB
May 30, 2012K120829STAINLESS STEEL SPINAL SYSTEM
Theken Spine, LLC
NKB
May 18, 2012K120928SYNTHES MATRIX SYSTEM
Synthes Spine
NKB
May 18, 2012K120091R&D INNOVATION PEDICLE SCREW SYSTEM
R&D Innovation, LLC
NKB
May 14, 2012K120571SYNTHES USS CONNECTOR
Synthes Spine
NKB
May 3, 2012K121020VIPER SYSTEM
Depuy Spine, Inc.
NKB
May 1, 2012K112684MONT BLANC PEDICLE SCREW SYSTEMS
Qualgenix
NKB
Apr 3, 2012K113361SECURIS SPINAL FIXATION
Cumtom Spine
NKB
Mar 29, 2012K113058TIGER SPINE SYSTEM
Corelink, LLC
NKB
Mar 26, 2012K120270VENUS SPINAL FIXATION SYSTEM
L&K BIOMED Co., Ltd., KR
NKB
Mar 14, 2012K120074FOUNDATION SPINAL SYSTEM
The Skeletal Design Partnership , Ltd.
NKB
Mar 9, 2012K120399LANX SPINAL FIXATION SYSTEM
Lanx, LLC
NKB
Mar 8, 2012K120434POWER ADAPTOR INSTRUMENT ACCESSORY
Stryker Corp.
NKB
Mar 7, 2012K120355LEUCADIA 4.5 MM PEDICLE SCREW SYSTEM
Phygen, LLC
NKB
Feb 16, 2012K111448ICON (TM) MODULAR PEDICLE SCREW SYSTEM
Orthofix, Inc.
NKB
Feb 15, 2012K120140FOCUS SPINAL SYSTEM
L&K BIOMED Co., Ltd., KR
NKB
Feb 9, 2012K113529CD HORIZON VOYAGER SPINAL SYSTEM
Medtronic Sofamor Danek
NKB
Feb 8, 2012K113396DEPUY PULSE THORACOLUMBAR SCREW SYSTEM
Medos International SARL
NKB
Feb 3, 2012K120047CORAL SPINAL SYSTEM
Theken Spine, LLC
NKB

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