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
+3K131784Range Spinal SystemK2m, Inc.201334—
+3K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+3K130877Expedium Spine SystemMedos International SARL20138—
+3K130330Range Spinal SystemK2m, Inc.201336—
+3K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+3K122571Malibu Spinal System with the Daytona Deformity SystemSeaspine, Inc.201262—
+3K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+3K120099Range Spinal System (Mesa and Denali)K2m, Inc.201253—
+3K113529CD Horizon Voyager Spinal SystemMedtronic Sofamor Danek2012316—
+3K110551Expedium Spine SystemJohnson & Johnson20111—
+3K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011597—
+3K112555CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011597—
+3K111942TSRH Spinal SystemsMedtronic Sofamor Danek USA, Inc.2011242—
+3K103671Genesys Spine Tilock SystemGenesys Spine20118—
+3K111076Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc.20115—
+3K103049TSRH Spinal SystemMedtronic Sofamor Danek2010244—
+3K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010598—
+3K102807CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2010517—
+3K100976T2 XVBR 1.5 Spinal SystemMedtronic Sofamor Danek USA, Inc.201049—
+3K102701Viper Spine SystemDepuy Spine, Inc.2010184—
+3K101070Expedium Spine SystemMedos International SARL20102601
+3K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems2010921
+3K100788Cocr RodsGlobus Medical, Inc.2010374—
+3K092076Aegis & Aegis II Spinal SystemCorentec Co., Ltd.20103—
+3K092605Xia 4.5 Spinal SystemStryker Spine200998—
+3K092473Expedium Spine SystemDepuy Spine, Inc.2009263—
+3K092624Firebird Spinal Fixation SystemBlackstone Medical, Inc.20091301
+3K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009776—
+3K0910675.5 Polaris Spinal SystemBiomet Spine200979—
+3K090648Viper 2 SystemDepuy Spine, Inc.2009337—
+3K082236CD Horizon Spinal SystemMedtronic Sofamor Danek2008779—
+3K082608Radius Spinal System, Vitallium Rod #486613601Stryker Spine2008200—
+3K073562Modification to Viper Spine SystemDepuy Spine, Inc.2008213—
+3K072605Malibu Spinal SystemSeaspine, Inc.200767—
+3K072426Atlas Spine Pedicle Screw SystemAtlas Spine, LLC200751
+3K071373Stryker Spine Xia Iii Spinal SystemStryker Spine20074301
+3K063670Modifications to CD Horizon Spinal SystemMedtronic Sofamor Danek2007821—
+3K070295Single Planar Multi Axial (Spma) Pedicle Screw SystemTrinity Orthopedics, LLC20070—
+3K062670Vertiflex Spinal Screw SystemVertiflex (Tm), Incorporated200712—
+3K061915CD Horizon Spinal SystemMedtronic Sofamor Danek200654—
+3K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006778—
+3K052747Modification to:CD Horizon Spinal SystemMedtronic Sofamor Danek2005528—
+3K052609Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek200554—
+3K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005780—
+3K051674CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005587—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+4K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+4K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+4K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+4K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+4K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+4K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+4K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+4K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+4K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+4K252437JAZZ Spinal SystemImplanet20250—
+4K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+4K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+4K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti.20243—
+4K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+4K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+4K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+4K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+4K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+4K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+4K240392JAZZ Spinal SystemImplanet20241—
+4K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+4K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+4K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+4K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+4K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+4K232561Ripley Spinal Screw System by SAGICOSagico VA USA, LLC20230—
+4K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+4K231479TriALTIS Spine SystemMedos International SARL20238—
+4K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+4K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+4K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+4K230369EUROPA™ Navigated InstrumentsMiRus, LLC20230—
+4K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+4K223764INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc.20230—
+4K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+4K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+4K223273ASTRA Spine SystemSpinecraft, LLC20228—
+4K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+4K222110Mariner RDX SystemSeaSpine Orthopedics Corporation202282
+4K221745Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co, Ltd.20220—
+4K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+4K221776NextGen Pedicle Screw SystemCorelink, LLC20222—