510(k) Report

Devices descending from K050079

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K120564Calypso SystemHogan Lovells US LLP201216—
+5K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+5K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+5K120928Synthes Matrix SystemSynthes Spine20120—
+6K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+6K261408SABER-XA SystemElevation Spine20260—
+6K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+6K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+6K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+6K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+6K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+6K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+6K253545Vulcan Spinal SystemK2m, Inc.20260—
+6K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc.20260—
+6K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+6K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+6K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+6K252742Navigated InstrumentsTyber Medical, LLC20251—
+6K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+6K252322SIros-X SystemGenesys Spine20250—
+6K253331PressON Spinal Fixation SystemNexus Spine20250—
+6K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+6K241525ExcelsiusXR™Globus Medical, Inc.20250—
+6K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+6K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+6K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+6K250182Innovasis Navigation InstrumentsInnovasis, Inc.202521
+6K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+6K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+6K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+6K241644SPINEART Navigation Instrument SystemSpineart SA20243—
+6K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+6K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+6K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+6K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+6K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+6K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+6K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+6K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+6K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+6K231515MySpine Cervical GuidesMedacta International S.A.20230—
+6K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+6K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+6K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+6K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+6K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+6K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+6K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+6K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+6K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+6K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+6K223808Zavation Navigation Instrument SystemZavation Medical Products, LLC20230—
+6K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+6K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+6K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+6K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+6K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+6K230482Swedge™ Pedicle Screw Fixation SystemSpinal Resources, Inc.20231—
+6K222105RESPONSE 5.5/6.0 Cannulated Screw SystemOrthoPediatrics Corp.20230—
+6K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+6K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+6K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+6K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+6K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+6K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+6K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+6K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+6K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+6K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+6K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+6K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+6K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+6K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+6K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+6K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+6K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+6K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+6K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+6K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+6K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+6K211740DualXAmplify Surgical, Inc.20211—
+6K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+6K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+6K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+6K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+6K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+6K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+6K201737Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co, Ltd.20211—
+6K211323ASTRA Spine SystemSpinecraft, LLC202112—
+6K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+6K210306GII Spinal Fixation SystemColigne AG20210—
+6K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH20216—
+6K210549ARx Spinal SystemLife Spine, Inc.20211—
+6K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+6K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+6K203816DeGen Navigated InstrumentationDegen Medical20211—
+6K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—