510(k) Report

Devices descending from K041030

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+6K241525ExcelsiusXR™Globus Medical, Inc.20250—
+6K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+6K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+6K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+6K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+6K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+6K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+6K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+6K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+6K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+6K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+6K241258Ingenix Spinal SystemIngenium Spine20240—
+6K240392JAZZ Spinal SystemImplanet20241—
+6K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+6K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+6K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+6K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+6K231515MySpine Cervical GuidesMedacta International S.A.20230—
+6K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+6K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+6K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+6K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+6K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+6K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+6K231479TriALTIS Spine SystemMedos International SARL20238—
+6K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+6K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+6K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+6K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+6K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+6K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+6K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+6K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+6K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+6K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+6K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+6K223764INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc.20230—
+6K223273ASTRA Spine SystemSpinecraft, LLC20228—
+6K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+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—
+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—
+6K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+6K221745Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co, Ltd.20220—
+6K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+6K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+6K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+6K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+6K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+6K220131KYPHON VuE Bone CementTecres S.P.A.20220—
+6K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+6K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+6K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+6K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+6K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+6K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+6K213918DeGen Navigated InstrumentationDegen Medical20220—
+6K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+6K211740DualXAmplify Surgical, Inc.20211—
+6K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+6K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+6K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+6K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+6K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+6K210549ARx Spinal SystemLife Spine, Inc.20211—
+6K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+6K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+6K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+6K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+6K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+6K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+6K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+6K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+6K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+6K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+6K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+6K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+6K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+6K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+6K201831CONFIDENCE Spinal Cement SystemDepuy Spine, Inc.20200—
+6K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+6K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+6K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+6K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+6K200303Reform Pedicle Screw SystemPrecision Spine202010—
+6K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+6K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+6K192818Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemStryker Corporation20208—
+6K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+6K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+6K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+6K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+6K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+6K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+6K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+6K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+6K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—