510(k) Report

Devices descending from P960025

1,714 later devices reach Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K132601Coroent Sterile Implants SystemNu Vasive, Incorporated2013596—
+3K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013119—
+3K131669Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.2013234—
+3K130254Prow FusionNlt Spine, Ltd.20138—
+3K130641Logic Stand-Alone Intervertebral Body Fusion DeviceBinder Biomedical, Inc.20130—
+3K130461Stalif XCentinel Spine, Inc.201313—
+3K130948C-Fuse Cervical Intervertebral Body Fusion SystemSouthern Spine, LLC201313—
+3K130820Expandable Lumbar Interbody SystemNu Vasive, Incorporated2013593—
+3K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc.2013709—
+3K122588Vusion CS PlusOrtho Development Corp.2013206—
+3K130699Aleutian Spinal SystemK2m, Inc.2013570—
+3K123045Brigade Standalone SystemNuvasive, Inc.2013696—
+3K120464Innesis Peek CageBk Meditech, Co., Ltd.20136—
+3K121649Construx Mini Peek TI Spacer SystemOrthofix2012289—
+3K121151Pro-Link Cervical Spacer SystemLife Spine, Inc.2012116—
+3K112700Frontier Sadl Interbody Fusion DeviceFrontier Medical Devices, Inc.20121—
+3K122168Visualif Challenging Access PlateSpine Smith Partners L.P.20121—
+3K122366Tryptik CC Anterior Intersomatic Cervical CageSpineart20125—
+3K122591Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.201214—
+3K120819Stalif CCentinel Spine, Inc.2012206—
+3K120991TRANS1 Interbody Fusion SystemTrans1 Incorporated2012172—
+3K121683Acculif TL CageCoalign Innovations, Inc.2012682—
+3K121211VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2012129—
+3K120203TM-400 DeviceZimmer Trabecular Metal Technology, Inc.201220—
+3K121246Medyssy LT Cage SystemMedyssey Co, Ltd.20122—
+3K120396Reliance Cervical Ibf SystemReliance Medical Systems, LLC201225—
+3K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+3K120557Solitarie Peek Anterior Spinal System-to BE Called Colitaire 35Biomet Spine & Bone Healing Technologies20121—
+3K120031Chesapeake Spinal SystemK2m, Inc.2012334—
+3K112561Nuvasive Coroent NO-Profile SystemNuvasive, Inc.201212—
+3K112405Clydesdales Spinal SystemMedtronic Sofamor Danek USA, Inc.2011296—
+3K111965Vusion (R) OSOrtho Development20110—
+3K110063Sovereign Spinal SystemMedtronic Sofamor Danek, Inc.2011718—
+3K112496Pioneer Crossfuse II Ibf/VBR SystemPioneer Surgical Technology, Inc.2011604—
+3K111626Endoskeleton (R) TasTitan Spine, LLC2011273—
+3K111675VU C*Pod Intervertebral Body Fusion DeviceTheken Spine, LLC201162—
+3K103369Vault Alif SystemSpinal USA201110—
+3K103743Concorde Curve SystemJohnson & Johnson20110—
+3K101301Stalif MidlineCentinel Spine2010474—
+3K100210TRANS1 Lateral Intervertebral Fusion Device, TTrans1 Incorporated2010175—
+3K100802Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc.2010461—
+3K100043Coroent XLR Standalone SystemNuvasive, Inc.2010744—
+3K093808Incite Innovation Stand Alone Interbody Fusion DeviceIncite Innovation, LLC2010113—
+3K093629Solitaire and Solitaire Peek Anterior Spinal SystemBiomet Spine20101431
+3K092211Chesapeake Spinal SystemK2m, Inc.2010450—
+3K092540C-PS Peek Optima Cervical Interbody Spacer, L-PS Peek Optima Lumbar Interbody SpacerRsb Spine, LLC201045—
+3K093242Patriot Transcontinental Llif SpacerGlobus Medical, Inc.2009921—
+3K091301Life Spine Stand-Alone Spacer SystemLife Spine2009473—
+3K083475Lucent MagnumSpinal Elements, Inc.2009834—
+3K082406Expandable Peek-Optima ImplantEbi, L.P.2009527—
+3K081711Lucent Magnum+Spinal Elements, Inc.20080—
+4K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+4K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+4K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+4K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+4K261408SABER-XA SystemElevation Spine20260—
+4K2530413d Cage CervicalFims Co., Ltd.20260—
+4K262094E3D™-C Interbody SystemEvolution Spine20260—
+4K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+4K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+4K261279DeltaNEC Interbody SystemNexus Spine20260—
+4K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+4K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+4K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+4K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+4K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+4K261067BEE PLIF CageNGMedical GmbH20260—
+4K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+4K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+4K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+4K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+4K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+4K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+4K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+4K260038E3D™-C Interbody SystemEvolution Spine20261—
+4K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+4K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+4K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+4K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+4K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+4K252742Navigated InstrumentsTyber Medical, LLC20251—
+4K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+4K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+4K253331PressON Spinal Fixation SystemNexus Spine20250—
+4K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+4K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+4K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+4K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+4K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+4K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+4K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+4K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+4K251741PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20250—
+4K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+4K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+4K251644ProAM ALIF SystemPro Surgical, Inc.20250—