510(k) Report

Devices descending from K040583

1,161 later devices reach Modification to: CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS…MANTIZ Co., Ltd.20260—
+6K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+6K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+6K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+6K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+6K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+6K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+6K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+6K253169Duet™ Spinal Fixation SystemBox Spine, LLC20261—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+6K252461Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, Inc.20260—
+6K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+6K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+6K252742Navigated InstrumentsTyber Medical, LLC20251—
+6K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+6K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+6K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+6K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+6K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+6K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+6K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K242042TriALTIS™ Spine SystemMedos International SARL20241—
+6K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+6K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+6K233256Robotic Integration InstrumentsDePuy Synthes20240—
+6K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+6K240963Spinal SystemTeslake, Inc.20240—
+6K240737G Surgical Marksman MIS SystemG Surgical, LLC20240—
+6K232432E3D™-A Interbody SystemEvolution Spine20248—
+6K233300POWEReam 1/4 DriveStryker Instruments20231—
+6K231515MySpine Cervical GuidesMedacta International S.A.20230—
+6K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+6K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+6K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+6K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+6K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+6K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+6K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+6K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+6K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+6K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+6K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+6K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+6K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+6K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+6K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+6K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+6K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+6K222789VADER® Pedicle System, G21 CementIcotec AG202352
+6K223294SpineJack® Expansion KitStryker Instruments20221—
+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—
+6K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+6K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+6K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+6K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+6K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+6K222698CUVIS-spineCurexo, Inc.20220—
+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—
+6K213876Spineology Navigation InstrumentsSpineology, Inc.20221—
+6K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+6K201788EDEN Spinal Fixation SystemJmt Co., Ltd.20221—
+6K211981KHEIRON® Spinal Fixation SystemS.M.A.I.O20228—
+6K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc.202232—
+6K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+6K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+6K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+6K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+6K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+6K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+6K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+6K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+6K213918DeGen Navigated InstrumentationDegen Medical20220—
+6K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+6K211740DualXAmplify Surgical, Inc.20211—
+6K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+6K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+6K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+6K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+6K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+6K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+6K203452Nano FortiFix® SystemNanovis, LLC20200—
+6K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+6K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+6K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+6K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+6K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+6K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+6K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—