510(k) Report

Devices descending from K040962

1,130 later devices reach Modification to CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+5K162786PASS LP Spinal SystemMedicrea International SA20176—
+5K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+5K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+5K161379ELSA SpacersGlobus Medical, Inc.2016155—
+5K162143FixxSure® X-LinkInnovasis, Inc.20160—
+5K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+5K161516G Surgical Marksman MIS SystemG Surgical, LLC20163—
+5K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+5K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+5K153404Zavation Spinal SystemZavation, LLC20161—
+5K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+5K160320PremierShandong Weigao Orthopaedic Device Co., Ltd.20161—
+5K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201587—
+5K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+5K152132X-spine Pedicle Screw SystemX-Spine Systems, Inc.201511
+5K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+5K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+5K143110GALAXY MIS Screw SystemBm Korea20152—
+5K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+5K151215Mercury Spinal SystemSpinal Elements, Inc.20158—
+5K142798PASS LP Spinal SystemMedicrea International SA201584—
+5K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.20150—
+5K150049PASS LP Spinal SystemMedicrea International20150—
+5K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+5K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group20141—
+5K140738Pass LP Spinal SystemMedicrea International201447—
+5K141850Flospine Pedicle Screw SystemFlospine20140—
+5K141372Mercury Spinal SystemSpinal Elements, Inc.20149—
+5K140219Picasso II Mis Spinal SystemAccel Spine20141—
+5K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+5K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+5K131833Centurion Poct SystemOrthofix, Inc.20142—
+5K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+5K132884Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20130—
+5K132574Pass LP Spinal SystemMedicrea International20130—
+5K132575Pass LP Spinal SystemMedicrea International20130—
+5K131802Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company2013139—
+5K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—
+5K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+5K130176Firebird Spinal Fixation SystemOrthofix20135—
+5K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+5K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+5K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+5K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+5K122845ES2 Spinal System Model 48280XXXXStryker Spine201228—
+5K123451Polaris Spinal System - Ballista II RodsBiomet Spine (Aka Ebi, LLC)20120—
+5K123246CD Horizon Spire Z Spinal SystemMedtronic Sofamor Danek20122—
+5K121728Tiger Spine SystemCorelink, LLC201250—
+5K121172Reform Pedicle Screw SystemSpinal USA201233—
+5K121671Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20120—
+5K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+5K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+5K112607Spinevision Lumis (TM) Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision…Spinevision S.A.20125—
+5K111940S 100 Pedicle Screw SystemRenovis Surgical Technologies, LLC201219—
+5K120571Synthes Uss ConnectorSynthes Spine201274—
+5K120696Tiger Spine SystemCorelink, LLC201241—
+5K113058Tiger Spine SystemCorelink, LLC201281—
+5K120140Focus Spinal SystemL&K BIOMED Co., Ltd.201225—
+5K111634Xenon (TM) Pedicle Screw SystemAlphatec Spine, Inc.20120—
+5K102235Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine2010109—
+5K091587Mercury Spinal SystemSpinal Elements, Inc.200910—
+5K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2007150—
+6K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+6K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+6K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+6K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS…MANTIZ Co., Ltd.20260—
+6K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+6K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+6K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+6K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+6K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+6K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+6K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+6K253169Duet™ Spinal Fixation SystemBox Spine, LLC20261—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K252461Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, Inc.20260—
+6K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+6K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+6K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+6K251943Spineology Navigation InstrumentsSpineology, Inc.20250—
+6K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+6K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+6K252742Navigated InstrumentsTyber Medical, LLC20251—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+6K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+6K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+6K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+6K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+6K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K242042TriALTIS™ Spine SystemMedos International SARL20241—
+6K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—