510(k) Report

Devices descending from K060615

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc.20141502
+6K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+6K132878M.U.S.T. ExtensionMedacta International201328—
+6K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+6K132757Everest Spinal SystemK2m, Inc.201341—
+6K132303Implanet Spine SystemImplanet, S.A.201315—
+6K132361Everest Spinal SystemK2m, Inc.201334—
+6K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+6K131784Range Spinal SystemK2m, Inc.201334—
+6K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+6K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+6K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+6K121922Beacon Stabilization SystemGlobus Medical, Inc.20129—
+7K261408SABER-XA SystemElevation Spine20260—
+7K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+7K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+7K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+7K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+7K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+7K260810Anteralign LS coverplateTyber Medical, LLC20260—
+7K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+7K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+7K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+7K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+7K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K253545Vulcan Spinal SystemK2m, Inc.20260—
+7K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+7K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+7K252461Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, Inc.20260—
+7K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+7K252742Navigated InstrumentsTyber Medical, LLC20251—
+7K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+7K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+7K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+7K252437JAZZ Spinal SystemImplanet20250—
+7K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+7K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+7K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+7K241525ExcelsiusXR™Globus Medical, Inc.20250—
+7K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+7K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+7K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+7K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+7K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+7K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+7K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+7K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+7K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+7K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+7K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+7K241258Ingenix Spinal SystemIngenium Spine20240—
+7K240392JAZZ Spinal SystemImplanet20241—
+7K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+7K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+7K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+7K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+7K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+7K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+7K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+7K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+7K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+7K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+7K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+7K231479TriALTIS Spine SystemMedos International SARL20238—
+7K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+7K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+7K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+7K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+7K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+7K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+7K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+7K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+7K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+7K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+7K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+7K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+7K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+7K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+7K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+7K223764INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc.20230—
+7K223273ASTRA Spine SystemSpinecraft, LLC20228—
+7K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+7K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+7K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+7K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+7K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+7K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+7K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+7K221745Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co, Ltd.20220—
+7K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+7K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+7K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+7K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+7K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+7K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+7K220131KYPHON VuE Bone CementTecres S.P.A.20220—