510(k) Report

Devices descending from K032265

1,192 later devices reach CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+5K180220SAGICO OSI Spinal System by OsimplantSpinal Analytics & Geometrical Implant Co, LLC20181—
+5K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+5K180433Ennovate®Aesculap Implant Systems, LLC201811
+5K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+5K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+5K180376K2M Patient Specific RodsK2m, Inc.20182—
+5K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+5K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+5K180176SeaSpine NewPort Spinal SystemSeaSpine Orthopedics Corporation20180—
+5K173882SeaSpine Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation2018561
+5K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemSilony Medical GmbH20186—
+5K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+5K173131Rexious Spinal Fixation SystemHuvexel Co., Ltd.20175—
+5K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+5K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+5K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+5K171570Additional VIPER PRIME™ screws with fenestrationsMedos International SARL201720—
+5K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+5K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+5K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+5K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+5K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+5K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+5K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+5K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+5K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+5K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+5K162764Jazz Frame SystemImplanet, S.A.20176—
+5K161379ELSA SpacersGlobus Medical, Inc.2016155—
+5K161535SeaSpine® NewPort™ Spinal SystemSeaSpine Orthopedics Corporation201614—
+5K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA20163—
+5K161369EVEREST Spinal SystemK2m, Incorporated20169—
+5K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+5K160902Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation201660—
+5K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+5K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+5K151977icotec Pedicle SystemIcotec AG201630—
+5K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+5K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+5K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+5K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+5K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+5K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+5K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+5K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+5K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+5K150294DPZ Pedicular Fixation SystemOsteomed Implantes, Ltda20150—
+5K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+5K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201588—
+5K143350Nile Alternative FixationK2m, Inc.201510—
+5K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+5K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+5K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+5K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+5K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC201410—
+5K140238Excella Iii-D Spinal Deformity SystemInnovasis, Inc.201432
+5K140449CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.201459—
+5K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+5K131888T2 XVBR Spinal System, T2 Altitude Expandable Corpectomy DeviceMedtronic Sofamor Danek, Inc.20130—
+5K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+5K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+5K130286Streamline Mis Spinal Fixation SystemPioneer Surgical Technology, Inc.201371
+5K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+5K123939S4 Spinal SystemAesculap Implant Systems, Inc.20133—
+5K123373Nautilus Spinal SystemLife Spine201317—
+5K123138Pass LP Spinal SystemMedicrea International2013132—
+5K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+5K122845ES2 Spinal System Model 48280XXXXStryker Spine201228—
+5K122901Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation SystemOrthofix2012116—
+5K123246CD Horizon Spire Z Spinal SystemMedtronic Sofamor Danek20122—
+5K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+5K121568Dali Spinal Fixation SystemAccel Spine20121—
+5K113666Xia 3 Spinal SystemStryker Spine2012251—
+5K122145Lanx Spinal Fixation SystemLanx, Inc.201271
+5K111953Nautilus Spinal SystemLife Spine20123—
+5K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+5K120434Power Adaptor Instrument AccessoryStryker Corp.201232—
+5K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+5K111957Polaris Spinal SystemBiomet Spine (Ebi, LLC)201176—
+5K111449Revolve Additional ImplantsGlobus Medical, Inc.2011236—
+5K111479Revere CrosstopGlobus Medical, Inc.2011232—
+5K111478Stryker Spine Power Adaptor (Accessory Instrument)Stryker Corporation201134—
+5K111183Ascent Posterior Occipital Thoracic (Poct) System (Titanium & Cobalt Chrome Rods)Orthofix, Inc.201122—
+5K110963Ellipse Occipito-Cervico-Thoracic Spinal SystemGlobus Medical, Inc.201198—
+5K102488Apex Spine System W/ Cocr RodsSpinecraft, LLC2010177—
+5K102235Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine2010109—
+5K093926Firebird Spinal Fixation SystemBlackstone Medical, Inc.201088—
+5K101144Modification to:Radius Spinal SystemStryker Spine201090—
+5K100044Firebird Spinal Fixation System, Firebird Side-Loading BodyBlackstone2010117—
+5K090320Conquest Spinal SystemLife Spine20092—
+5K091291Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium RodStryker Spine2009169—
+5K083393Xia 3 Spinal SystemStryker Spine20092921
+5K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2007150—
+6K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC20260—
+6K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.20260—
+6K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+6K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—