510(k) Report

Devices descending from K032265

1,192 later devices reach CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+6K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+6K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+6K181188EVEREST Spinal SystemK2m, Inc.20186—
+6K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+6K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+6K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+6K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+6K171881JAZZ Passer BandImplanet, S.A.20170—
+6K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+6K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd.201730—
+6K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+6K163181TRANSLACE™ Spinal Tethering SystemMedtronic Sofamor Danek USA, Inc.20172—
+6K170647Connector SystemOrthofix, Inc.201718—
+6K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+6K161332NILE Proximal Fixation Spinal SystemK2m, Inc.20175—
+6K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+6K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+6K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+6K162367Erisma® LP MISClariance, Sas20162—
+6K162143FixxSure® X-LinkInnovasis, Inc.20160—
+6K161516G Surgical Marksman MIS SystemG Surgical, LLC20163—
+6K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+6K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc.20160—
+6K160320PremierShandong Weigao Orthopaedic Device Co., Ltd.20161—
+6K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+6K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201587—
+6K152132X-spine Pedicle Screw SystemX-Spine Systems, Inc.201511
+6K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+6K142798PASS LP Spinal SystemMedicrea International SA201584—
+6K150049PASS LP Spinal SystemMedicrea International20150—
+6K141398Pass LP Spinal SystemMedicrea International SA2015101
+6K140738Pass LP Spinal SystemMedicrea International201447—
+6K132765PFX Spinous Process Fixation SystemInnovasis, Inc.20140—
+6K140400ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20149—
+6K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+6K131833Centurion Poct SystemOrthofix, Inc.20142—
+6K132574Pass LP Spinal SystemMedicrea International20130—
+6K132575Pass LP Spinal SystemMedicrea International20130—
+6K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+6K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—
+6K131100Streamline TL Spinal SystemPioneer Surgical Technology, Inc.20136—
+6K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+6K130176Firebird Spinal Fixation SystemOrthofix20135—
+6K123656Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.201339—
+6K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+6K112607Spinevision Lumis (TM) Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision…Spinevision S.A.20125—
+6K111940S 100 Pedicle Screw SystemRenovis Surgical Technologies, LLC201219—
+6K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011106—
+6K103292Trio Trauma Spinal SystemStryker Corporation201185—
+6K073420Blackstone Ascent Multiaxial ScrewsBlackstone Medical, Inc.20089—
+7K261408SABER-XA SystemElevation Spine20260—
+7K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS…MANTIZ Co., Ltd.20260—
+7K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+7K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+7K260810Anteralign LS coverplateTyber Medical, LLC20260—
+7K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+7K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+7K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+7K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+7K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+7K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+7K251943Spineology Navigation InstrumentsSpineology, Inc.20250—
+7K252742Navigated InstrumentsTyber Medical, LLC20251—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+7K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+7K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+7K251725ANAX™ OCT Spinal SystemCg Medtech Co., Ltd.20250—
+7K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K250637VCFix Spinal SystemAmber Implants20250—
+7K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+7K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+7K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+7K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+7K241846E3D™-C Interbody SystemEvolution Spine20246—
+7K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+7K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+7K240963Spinal SystemTeslake, Inc.20240—
+7K240368E3D™-A Interbody SystemEvolution Spine20247—
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+7K240526POWEReam Xia/SerratoStryker Instruments20240—
+7K240737G Surgical Marksman MIS SystemG Surgical, LLC20240—
+7K232628VADER® Pedicle SystemIcotec AG20241—
+7K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+7K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+7K233366SYMPHONY OCT SystemMedos International SARL20230—
+7K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+7K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+7K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+7K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+7K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+7K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+7K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+7K230989Rod Registration FrameNu Vasive, Incorporated20230—
+7K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+7K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+7K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—