510(k) Report

Devices descending from K011508

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+7K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+7K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+7K170543VIPER PRIME™ Screws with FenestrationsMedos International SARL201748—
+7K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+7K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+7K162764Jazz Frame SystemImplanet, S.A.20176—
+7K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+7K160926F1 MPS Modular Pedicle Screw SystemDegen Medical20161—
+7K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+7K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+7K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+7K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+7K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+7K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+7K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+7K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+7K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+7K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201588—
+7K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201584—
+7K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+7K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+7K142499Reline SystemNu Vasive, Incorporated201478—
+7K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+7K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+7K132361Everest Spinal SystemK2m, Inc.201334—
+7K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+8K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+8K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+8K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+8K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+8K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+8K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+8K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+8K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+8K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+8K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+8K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+8K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+8K241525ExcelsiusXR™Globus Medical, Inc.20250—
+8K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+8K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+8K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+8K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+8K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+8K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+8K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+8K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+8K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K243249TriALTIS™ Spine SystemMedos International SARL20250—
+8K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+8K243693NEO Pedicle Screw System™Neo Medical SA20240—
+8K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+8K240160EGPS Navigated InstrumentsAstura Medical20240—
+8K241846E3D™-C Interbody SystemEvolution Spine20246—
+8K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+8K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+8K240526POWEReam Xia/SerratoStryker Instruments20240—
+8K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+8K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+8K233684TriALTIS™ Spine SystemMedos International SARL20234—
+8K231515MySpine Cervical GuidesMedacta International S.A.20230—
+8K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+8K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+8K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+8K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+8K231658VEOS Spinal Fixation SystemSpineway20230—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+8K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+8K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+8K223558CUVIS-spineCurexo, Inc.20230—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+8K230026SqualeImplanet, S.A.20230—
+8K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+8K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+8K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+8K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+8K213876Spineology Navigation InstrumentsSpineology, Inc.20221—
+8K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+8K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+8K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+8K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+8K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+8K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+8K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+8K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+8K210574NuVasive Pulse SystemNu Vasive, Incorporated202121