510(k) Report

Devices descending from K052747

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+4K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+4K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201587—
+4K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+4K151727Everest Spinal SystemK2m, Inc.201511—
+4K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+4K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+4K151216Everest Spinal SystemK2m, Inc.201511—
+4K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+4K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+4K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+4K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+4K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+4K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+4K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+4K133402K2M Modular HooksK2m, Inc.20140—
+4K140529Everest Spinal SystemK2m, LLC201431—
+4K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+4K140010Fortress Pedicle Screw SystemSpineology, Inc.201411—
+4K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+4K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+4K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+4K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+4K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+4K132866Nautilus Spinal SystemLife Spine, Inc.201315—
+4K132361Everest Spinal SystemK2m, Inc.201334—
+4K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+5K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+5K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+5K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+5K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+5K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+5K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+5K253331PressON Spinal Fixation SystemNexus Spine20250—
+5K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+5K252437JAZZ Spinal SystemImplanet20250—
+5K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+5K241525ExcelsiusXR™Globus Medical, Inc.20250—
+5K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+5K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+5K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+5K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+5K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+5K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+5K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+5K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+5K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+5K240160EGPS Navigated InstrumentsAstura Medical20240—
+5K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+5K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+5K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+5K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+5K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+5K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+5K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+5K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+5K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+5K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+5K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+5K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+5K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+5K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+5K233300POWEReam 1/4 DriveStryker Instruments20231—
+5K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+5K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+5K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+5K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+5K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+5K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+5K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+5K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K231479TriALTIS Spine SystemMedos International SARL20238—
+5K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+5K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+5K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+5K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+5K223558CUVIS-spineCurexo, Inc.20230—
+5K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+5K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+5K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+5K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+5K213876Spineology Navigation InstrumentsSpineology, Inc.20221—
+5K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+5K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+5K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+5K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+5K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+5K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+5K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+5K220025ARx® Spinal SystemLife Spine, Inc.20220—
+5K213918DeGen Navigated InstrumentationDegen Medical20220—
+5K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+5K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+5K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—