510(k) Report

Devices descending from K142591

212 later devices reach CD HORIZON Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+1K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+1K152457CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2015145—
+1K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+2K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+2K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+2K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+2K221244CD Horizon™ Spinal SystemMedtronic202220—
+2K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+2K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+2K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+2K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+2K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+2K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+2K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+2K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+2K180324Patriot Spinal Fixation SystemValorus Spine20180—
+2K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+2K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+2K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+2K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+2K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+2K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+2K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemSurgtech, Inc.20170—
+2K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.20162—
+2K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201645—
+2K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+2K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+2K153589CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201610—
+3K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+3K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+3K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+3K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+3K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+3K252322SIros-X SystemGenesys Spine20250—
+3K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+3K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+3K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+3K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+3K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+3K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+3K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+3K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+3K223494CD Horizon Spinal SystemMedtronic202317—
+3K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+3K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+3K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+3K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+3K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+3K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+3K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+3K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+3K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+3K202328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20200—
+3K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+3K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+3K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+3K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+3K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+3K172115Navigated Instrument SystemOrthofix, Inc.20184—
+3K173126Arisstos™ Spinal SystemIngenium Spine20171—
+3K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+3K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+3K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K162921Navigated Instrument SystemOrthofix, Inc.20175—
+3K161842Overwatch Spine SystemAmendia, Inc.201661
+3K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+4K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+4K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+4K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+4K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+4K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+4K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+4K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+4K253331PressON Spinal Fixation SystemNexus Spine20250—
+4K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+4K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+4K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+4K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+4K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+4K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+4K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+4K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+4K241258Ingenix Spinal SystemIngenium Spine20240—
+4K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+4K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+4K232432E3D™-A Interbody SystemEvolution Spine20248—
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+4K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+4K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+4K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+4K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+4K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+4K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—