510(k) Report

Devices descending from K070229

598 later devices reach Range Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.20260—
+7K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+7K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+7K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+7K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+7K252437JAZZ Spinal SystemImplanet20250—
+7K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+7K241525ExcelsiusXR™Globus Medical, Inc.20250—
+7K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+7K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+7K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+7K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+7K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+7K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+7K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+7K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+7K240160EGPS Navigated InstrumentsAstura Medical20240—
+7K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+7K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+7K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+7K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+7K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+7K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+7K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+7K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+7K231658VEOS Spinal Fixation SystemSpineway20230—
+7K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+7K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+7K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+7K223806VERTICALE® Triangular Fixation SystemSilony Medical GmbH20230—
+7K223558CUVIS-spineCurexo, Inc.20230—
+7K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+7K230762EDEN Spinal Fixation MIS SystemJmt Co., Ltd.20230—
+7K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+7K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+7K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+7K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+7K223494CD Horizon Spinal SystemMedtronic202317—
+7K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+7K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+7K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+7K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+7K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+7K201569CUVIS-spineCurexo, Inc.20212—
+7K210549ARx Spinal SystemLife Spine, Inc.20211—
+7K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+7K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+7K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+7K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+7K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+7K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+7K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+7K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+7K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+7K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+7K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+7K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+7K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+7K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+7K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+7K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+7K191217Jazz PFImplanet, S.A.20190—
+7K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+7K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+7K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+7K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+7K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+7K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+7K183117PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.20184—
+7K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+7K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+7K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+7K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+7K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+7K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+7K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+7K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+7K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+7K171881JAZZ Passer BandImplanet, S.A.20170—
+7K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+7K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+7K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+7K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+7K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+8K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.20260—
+8K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+8K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+8K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+8K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+8K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+8K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+8K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+8K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—