510(k) Report

Devices descending from K020709

1,146 later devices reach Modification to CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+6K161766PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.201618—
+6K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA20163—
+6K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc.20160—
+6K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+6K151977icotec Pedicle SystemIcotec AG201630—
+6K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+6K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201587—
+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
+6K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+6K140738Pass LP Spinal SystemMedicrea International201447—
+6K132765PFX Spinous Process Fixation SystemInnovasis, Inc.20140—
+6K132574Pass LP Spinal SystemMedicrea International20130—
+6K132575Pass LP Spinal SystemMedicrea International20130—
+6K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+6K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+6K131100Streamline TL Spinal SystemPioneer Surgical Technology, Inc.20136—
+6K123656Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.201339—
+6K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+6K112607Spinevision Lumis (TM) Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision…Spinevision S.A.20125—
+6K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011106—
+6K093434Vertex Reconstruction System and Vertex Select Reconstruction SystemMedtronic Sofamor Danek20097—
+6K073420Blackstone Ascent Multiaxial ScrewsBlackstone Medical, Inc.20089—
+7K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+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—
+7K253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.20260—
+7K260810Anteralign LS coverplateTyber Medical, LLC20260—
+7K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+7K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+7K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, 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—
+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—
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K250637VCFix Spinal SystemAmber Implants20250—
+7K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20250—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+7K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+7K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+7K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+7K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+7K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+7K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+7K241846E3D™-C Interbody SystemEvolution Spine20246—
+7K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20241—
+7K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+7K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+7K240368E3D™-A Interbody SystemEvolution Spine20247—
+7K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, 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
+7K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+7K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+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—
+7K223806VERTICALE® Triangular Fixation SystemSilony Medical GmbH20230—
+7K230762EDEN Spinal Fixation MIS SystemJmt Co., Ltd.20230—
+7K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+7K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+7K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+7K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+7K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+7K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+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—
+7K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+7K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+7K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+7K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+7K211981KHEIRON® Spinal Fixation SystemS.M.A.I.O20228—
+7K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.20221—
+7K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+7K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+7K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+7K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+7K211740DualXAmplify Surgical, Inc.20211—
+7K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+7K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+7K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+7K203023Pisces Spinal SystemOrtho Development Corporation20210—
+7K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+7K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+7K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+7K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—