510(k) Report

Devices descending from K113529

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+5K240160EGPS Navigated InstrumentsAstura Medical20240—
+5K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+5K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+5K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+5K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+5K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+5K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+5K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+5K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+5K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+5K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+5K223558CUVIS-spineCurexo, Inc.20230—
+5K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+5K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+5K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+5K223273ASTRA Spine SystemSpinecraft, LLC20228—
+5K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+5K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+5K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+5K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+5K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+5K201569CUVIS-spineCurexo, Inc.20212—
+5K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+5K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+5K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+5K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+5K200896Solstice CCILife Spine, Inc.20200—
+5K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+5K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+5K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+5K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+5K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+5K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+5K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+5K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+5K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+5K172194Connector SystemOrthofix, Inc.2017162
+5K151216Everest Spinal SystemK2m, Inc.201511—
+6K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+6K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+6K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+6K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+6K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+6K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+6K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+6K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+6K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+6K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+6K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+6K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+6K233256Robotic Integration InstrumentsDePuy Synthes20240—
+6K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+6K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+6K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+6K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+6K231658VEOS Spinal Fixation SystemSpineway20230—
+6K230989Rod Registration FrameNu Vasive, Incorporated20230—
+6K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+6K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+6K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+6K222698CUVIS-spineCurexo, Inc.20220—
+6K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+6K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+6K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+6K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+6K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+6K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+6K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+6K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+6K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+6K190751Connector SystemOrthofix, Inc.20193—
+6K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+7K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+7K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+7K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+7K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+7K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+7K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+7K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+7K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+7K241846E3D™-C Interbody SystemEvolution Spine20246—
+7K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+7K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+7K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+7K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+7K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+7K220025ARx® Spinal SystemLife Spine, Inc.20220—
+7K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+7K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+7K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+7K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+7K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—