510(k) Report

Devices descending from K113174

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+3K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201588—
+3K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+3K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+3K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201584—
+3K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+3K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+3K143403Threshold Pedicular Fixation SystemSpineology, Inc.20148—
+3K142499Reline SystemNu Vasive, Incorporated201478—
+3K142381Xia 3 Spinal SystemStryker Corp.201483—
+3K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+3K133402K2M Modular HooksK2m, Inc.20140—
+3K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+3K132866Nautilus Spinal SystemLife Spine, Inc.201315—
+3K132361Everest Spinal SystemK2m, Inc.201334—
+3K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+4K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+4K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+4K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+4K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+4K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+4K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+4K253249TriALTIS™ Spine SystemMedos International SARL20251—
+4K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+4K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+4K241525ExcelsiusXR™Globus Medical, Inc.20250—
+4K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+4K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+4K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+4K243249TriALTIS™ Spine SystemMedos International SARL20250—
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+4K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K243693NEO Pedicle Screw System™Neo Medical SA20240—
+4K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+4K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+4K240160EGPS Navigated InstrumentsAstura Medical20240—
+4K241644SPINEART Navigation Instrument SystemSpineart SA20243—
+4K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+4K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+4K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+4K241258Ingenix Spinal SystemIngenium Spine20240—
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+4K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+4K233684TriALTIS™ Spine SystemMedos International SARL20234—
+4K231515MySpine Cervical GuidesMedacta International S.A.20230—
+4K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+4K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+4K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+4K231658VEOS Spinal Fixation SystemSpineway20230—
+4K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+4K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+4K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+4K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+4K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+4K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+4K223558CUVIS-spineCurexo, Inc.20230—
+4K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+4K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+4K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+4K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+4K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+4K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+4K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+4K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+4K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+4K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+4K213876Spineology Navigation InstrumentsSpineology, Inc.20221—
+4K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+4K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+4K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+4K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+4K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+4K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+4K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+4K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+4K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+4K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+4K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+4K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+4K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+4K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+4K201569CUVIS-spineCurexo, Inc.20212—
+4K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+4K210549ARx Spinal SystemLife Spine, Inc.20211—
+4K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+4K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+4K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+4K203816DeGen Navigated InstrumentationDegen Medical20211—
+4K210472SPINEART Navigation Instrument SystemSpineart20215—
+4K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+4K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+4K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—