510(k) Report

Devices descending from K001255

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+6K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+6K161369EVEREST Spinal SystemK2m, Incorporated20169—
+6K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+6K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+6K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+6K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201587—
+6K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+6K151727Everest Spinal SystemK2m, Inc.201511—
+6K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+6K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+6K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+6K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+6K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+6K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+6K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+6K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+6K140734Nextgen Altius Oct SystemEbi, LLC20140—
+6K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+6K133402K2M Modular HooksK2m, Inc.20140—
+6K133556Virage Oct Spinal Fixation SystemZimmer Spine, Inc.2014272
+6K140529Everest Spinal SystemK2m, LLC201431—
+6K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+6K140010Fortress Pedicle Screw SystemSpineology, Inc.201411—
+6K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+6K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+6K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+6K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+6K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+6K132866Nautilus Spinal SystemLife Spine, Inc.201315—
+6K132361Everest Spinal SystemK2m, Inc.201334—
+6K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+6K121877Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod…Exactech, Inc.20134—
+6K122378Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)201271
+6K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012102—
+6K113346Neon SystemUlrich GmbH & Co. KG20121—
+6K111076Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc.20115—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+7K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+7K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+7K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+7K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+7K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+7K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+7K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+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—
+7K253331PressON Spinal Fixation SystemNexus Spine20250—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+7K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+7K241525ExcelsiusXR™Globus Medical, Inc.20250—
+7K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+7K250637VCFix Spinal SystemAmber Implants20250—
+7K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20250—
+7K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+7K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+7K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+7K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+7K243249TriALTIS™ Spine SystemMedos International SARL20250—
+7K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+7K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+7K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+7K240160EGPS Navigated InstrumentsAstura Medical20240—
+7K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20241—
+7K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+7K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+7K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+7K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+7K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+7K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+7K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+7K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+7K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+7K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+7K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+7K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+7K233684TriALTIS™ Spine SystemMedos International SARL20234—
+7K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+7K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+7K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+7K233366SYMPHONY OCT SystemMedos International SARL20230—
+7K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+7K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+7K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+7K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+7K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+7K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+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—
+7K223558CUVIS-spineCurexo, Inc.20230—
+7K230614Cortium™Ulrich Medical USA20230—
+7K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302