510(k) Report

Devices descending from K001066

768 later devices reach CD Horizon Eclipse through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+7K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+7K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+7K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+7K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+7K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+7K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+7K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+7K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+7K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+7K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+7K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+7K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+7K252322SIros-X SystemGenesys Spine20250—
+7K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+7K253331PressON Spinal Fixation SystemNexus Spine20250—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+7K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+7K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+7K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+7K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+7K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+7K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+7K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+7K233256Robotic Integration InstrumentsDePuy Synthes20240—
+7K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+7K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+7K241258Ingenix Spinal SystemIngenium Spine20240—
+7K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+7K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+7K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+7K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+7K233300POWEReam 1/4 DriveStryker Instruments20231—
+7K231515MySpine Cervical GuidesMedacta International S.A.20230—
+7K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+7K233527Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion…Spinal Simplicity, LLC20232—
+7K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+7K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+7K233366SYMPHONY OCT SystemMedos International SARL20230—
+7K231479TriALTIS Spine SystemMedos International SARL20238—
+7K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+7K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+7K221307Edge Upper Cervical SystemSpinal Simplicity, LLC20230—
+7K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+7K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+7K230614Cortium™Ulrich Medical USA20230—
+7K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+7K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+7K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+7K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+7K222698CUVIS-spineCurexo, Inc.20220—
+7K213876Spineology Navigation InstrumentsSpineology, Inc.20221—
+7K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+7K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+7K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+7K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+7K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+7K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+7K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+7K211880Minuteman G5 MIS Fusion PlateSpinal Simplicity, LLC20224—
+7K213918DeGen Navigated InstrumentationDegen Medical20220—
+7K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+7K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+7K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+7K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+7K210306GII Spinal Fixation SystemColigne AG20210—
+7K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+7K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+7K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+7K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+7K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+7K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+7K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+7K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+7K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+7K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+7K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+7K191217Jazz PFImplanet, S.A.20190—
+7K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+7K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+7K190751Connector SystemOrthofix, Inc.20193—
+7K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+7K182182YUKON OCT Spinal SystemK2m20185—
+7K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+7K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+7K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+7K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+7K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+7K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—