510(k) Report

Devices descending from K841189

2,425 later devices reach Oec/Rezaian Spinal Fixator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K103660Lanx Cervical Intervertebral Body Fusion SystemLanx, Inc.201141—
+5K102738Lanx Fusion SystemLanx, LLC20113281
+5K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+5K102293Caliber SpacerGlobus Medical, Inc.2011869—
+5K101363VU Cpod Intervertebral Bodu Fusion DeviceMusculoskeletal Clinical Regulatory Advisers201078—
+5K102313Patriot Transcontinental M SpacersGlobus Medical, Inc.2010361—
+5K102067Endoskeleton toTitan Spine, LLC2010337—
+5K100976T2 XVBR 1.5 Spinal SystemMedtronic Sofamor Danek USA, Inc.201049—
+5K101051Avs a-Lat Peek Spacers, Models 48750XXX, 48751XXX, 48752XXX, 48753XXXStryker Spine2010641—
+5K092325Modification to:CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20093—
+5K091883T2 Spinal SystemMedtronic Sofamor Danek USA, Inc.200951—
+5K090315Staxx XD SystemSpine Wave, Inc.20096—
+5K091587Mercury Spinal SystemSpinal Elements, Inc.200910—
+5K082698Aleutian Ibf SystemK2m, Inc.2009662—
+5K082732Modification to: Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008710—
+5K081880Atlas Spine SpacerAtlas Spine, Inc.20080—
+5K082270Octane Vertebral Body Replacement (VBR) SystemVertiflex, Inc.200855—
+5K073285Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc.2008637—
+5K073177Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology20087751
+5K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.20071,405—
+5K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2007150—
+5K071497Atlas Spine Vertebral Body ReplacementAtlas Spine, Inc.20070—
+5K063399Aleutian Spacer SystemK2m, Inc.2007663—
+5K061082Mobis Spinal ImplantSignus Medizintechnik GmbH20060—
+5K062606CD Horizon Spinal SystemMedtronic Sofamor Danek20062—
+5K060350Construx PL/TL Peek Partial VBR SystemBlackstone Medical, Inc.2006754—
+5K051659Semial Spinal ImplantSignus Medizintechnik GmbH2005790—
+5K043316Rabea Spinal ImplantSignus Medizintechnik GmbH20051,005—
+6K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+6K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+6K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+6K261049Scala® TLSpineart SA20260—
+6K261408SABER-XA SystemElevation Spine20260—
+6K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+6K2530413d Cage CervicalFims Co., Ltd.20260—
+6K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+6K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+6K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+6K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+6K261067BEE PLIF CageNGMedical GmbH20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+6K253260ORIO-3D Cage SystemSpineCraft20260—
+6K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+6K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+6K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+6K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc.20260—
+6K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+6K253266Titanium Interbody SystemSpine Innovation, LLC20260—
+6K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+6K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+6K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+6K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+6K250560BEE HANGMedical GmbH20250—
+6K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+6K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+6K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+6K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+6K252322SIros-X SystemGenesys Spine20250—
+6K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+6K253331PressON Spinal Fixation SystemNexus Spine20250—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+6K251741PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20250—
+6K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+6K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+6K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+6K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+6K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+6K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+6K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+6K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+6K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+6K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+6K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+6K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+6K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+6K250182Innovasis Navigation InstrumentsInnovasis, Inc.202521
+6K250186GoLIF! Lumbar Interbody Fusion SystemGetset Surgical, SA20250—
+6K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+6K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+6K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+6K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+6K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+6K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+6K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+6K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K243670Idys® LIFClariance20240—
+6K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+6K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—