510(k) Report

Devices descending from K102807

517 later devices reach CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+5K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+5K253331PressON Spinal Fixation SystemNexus Spine20250—
+5K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+5K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+5K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+5K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+5K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+5K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+5K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+5K233256Robotic Integration InstrumentsDePuy Synthes20240—
+5K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+5K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+5K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+5K240526POWEReam Xia/SerratoStryker Instruments20240—
+5K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+5K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+5K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+5K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+5K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+5K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+5K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+5K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+5K231479TriALTIS Spine SystemMedos International SARL20238—
+5K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+5K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+5K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+5K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+5K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+5K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+5K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+5K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+5K222698CUVIS-spineCurexo, Inc.20220—
+5K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+5K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+5K213876Spineology Navigation InstrumentsSpineology, Inc.20221—
+5K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+5K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+5K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+5K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+5K213918DeGen Navigated InstrumentationDegen Medical20220—
+5K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+5K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+5K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+5K211323ASTRA Spine SystemSpinecraft, LLC202112—
+5K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+5K210306GII Spinal Fixation SystemColigne AG20210—
+5K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+5K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+5K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+5K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+5K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+5K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+5K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+5K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+5K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+5K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+5K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+5K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+5K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+5K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+5K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+5K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+5K180433Ennovate®Aesculap Implant Systems, LLC201811
+5K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+5K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+5K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+5K173126Arisstos™ Spinal SystemIngenium Spine20171—
+5K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+5K172194Connector SystemOrthofix, Inc.2017162
+5K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+5K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+5K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+5K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+5K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+5K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+5K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+5K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+5K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201587—
+5K150390Nautilus Spinal SystemLife Spine, Inc.20150—
+5K143403Threshold Pedicular Fixation SystemSpineology, Inc.20148—
+5K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+6K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+6K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+6K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+6K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+6K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+6K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—