510(k) Report

Devices descending from K032033

1,106 later devices reach CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K132878M.U.S.T. ExtensionMedacta International201328—
+4K132884Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20130—
+4K132866Nautilus Spinal SystemLife Spine, Inc.201315—
+4K132361Everest Spinal SystemK2m, Inc.201334—
+4K131802Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company2013139—
+4K131250Tiger Spine SystemCorelink, LLC201340—
+4K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+4K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+4K131343Reform Pedicle Screw SystemSpinal USA201331—
+4K130877Expedium Spine SystemMedos International SARL20138—
+4K130279Reform Pedicle Screw SystemSpinal USA201331—
+4K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013195—
+4K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+4K131030Range Spinal SystemK2m, Inc.201334—
+4K122877Range Spinal System, Small StatureK2m, Inc.201334—
+4K130646CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013244—
+4K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+4K122592Instinct Java SystemZimmer Spine201301
+4K122845ES2 Spinal System Model 48280XXXXStryker Spine201228—
+4K123451Polaris Spinal System - Ballista II RodsBiomet Spine (Aka Ebi, LLC)20120—
+4K123246CD Horizon Spire Z Spinal SystemMedtronic Sofamor Danek20122—
+4K122433CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.201239—
+4K121630Range Spinal SystemK2m, Inc.2012127—
+4K120838Synthes Matrix SystemSynthes Spine201216—
+4K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+4K121671Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20120—
+4K120564Calypso SystemHogan Lovells US LLP201216—
+4K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+4K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+4K120899Range Spinal System, Unit RodK2m, Inc.201235—
+4K120099Range Spinal System (Mesa and Denali)K2m, Inc.201253—
+4K111940S 100 Pedicle Screw SystemRenovis Surgical Technologies, LLC201219—
+4K120571Synthes Uss ConnectorSynthes Spine201274—
+4K121020Viper SystemDepuy Spine, Inc.201294—
+4K120656Everest Spinal SystemK2m, Inc.201243—
+4K113058Tiger Spine SystemCorelink, LLC201281—
+4K110551Expedium Spine SystemJohnson & Johnson20111—
+4K103292Trio Trauma Spinal SystemStryker Corporation201185—
+4K102870Exactech Proliant Polyaxial Pedicle Screw SystemExactech, Inc.20119—
+4K101070Expedium Spine SystemMedos International SARL20102601
+4K102235Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine2010109—
+4K101144Modification to:Radius Spinal SystemStryker Spine201090—
+4K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems2010921
+4K092473Expedium Spine SystemDepuy Spine, Inc.2009263—
+4K0910675.5 Polaris Spinal SystemBiomet Spine200979—
+4K080767Conquest Spinal SystemLife Spine200821—
+4K073245Extended Vertiflex Spinal Screw SystemVertiflex, Inc.200810—
+4K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2007150—
+4K062606CD Horizon Spinal SystemMedtronic Sofamor Danek20062—
+5K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+5K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+5K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+5K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+5K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+5K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+5K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+5K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+5K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+5K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+5K253169Duet™ Spinal Fixation SystemBox Spine, LLC20261—
+5K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc.20260—
+5K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+5K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+5K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+5K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+5K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K253249TriALTIS™ Spine SystemMedos International SARL20251—
+5K253331PressON Spinal Fixation SystemNexus Spine20250—
+5K252437JAZZ Spinal SystemImplanet20250—
+5K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+5K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+5K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+5K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+5K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+5K250182Innovasis Navigation InstrumentsInnovasis, Inc.202521
+5K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+5K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+5K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+5K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+5K241644SPINEART Navigation Instrument SystemSpineart SA20243—
+5K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+5K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+5K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+5K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+5K240392JAZZ Spinal SystemImplanet20241—
+5K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+5K240526POWEReam Xia/SerratoStryker Instruments20240—
+5K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+5K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+5K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+5K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+5K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—