510(k) Report

Devices descending from K031655

1,220 later devices reach CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K151977icotec Pedicle SystemIcotec AG201630—
+6K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+6K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+6K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201587—
+6K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+6K132765PFX Spinous Process Fixation SystemInnovasis, Inc.20140—
+6K140400ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20149—
+6K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+6K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+6K130302Spinevision Lumis Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision…Spinevision S.A.20134—
+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—
+6K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011106—
+6K103292Trio Trauma Spinal SystemStryker Corporation201185—
+6K073420Blackstone Ascent Multiaxial ScrewsBlackstone Medical, Inc.20089—
+7K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC20260—
+7K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+7K261408SABER-XA SystemElevation Spine20260—
+7K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+7K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+7K253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.20260—
+7K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+7K260810Anteralign LS coverplateTyber Medical, LLC20260—
+7K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+7K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+7K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+7K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+7K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+7K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+7K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+7K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+7K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+7K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+7K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+7K251943Spineology Navigation InstrumentsSpineology, Inc.20250—
+7K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+7K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+7K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+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—
+7K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+7K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+7K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+7K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+7K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+7K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+7K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+7K232628VADER® Pedicle SystemIcotec AG20241—
+7K233366SYMPHONY OCT SystemMedos International SARL20230—
+7K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+7K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+7K223806VERTICALE® Triangular Fixation SystemSilony Medical GmbH20230—
+7K230762EDEN Spinal Fixation MIS SystemJmt Co., Ltd.20230—
+7K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+7K230989Rod Registration FrameNu Vasive, Incorporated20230—
+7K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+7K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+7K230026SqualeImplanet, S.A.20230—
+7K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+7K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+7K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.202220—
+7K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+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—
+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—
+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—
+7K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+7K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+7K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+7K200322Altus Spine Pedicle Screw SystemAltus Partners, LLC20204—
+7K193465CorticaLINK Spinal Fusion PlatformSpine Smith Holdings, LLC20200—
+7K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+7K191810Curiteva Pedicle Screw SystemCuriteva, Inc.20190—
+7K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+7K190751Connector SystemOrthofix, Inc.20193—
+7K182470Plateau Spacer SystemLife Spine20180—
+7K182182YUKON OCT Spinal SystemK2m20185—
+7K183117PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.20184—
+7K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+7K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+7K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+7K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+7K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+7K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+7K173484CorticaLINK Spinal Fusion PlatformLinkspine, Inc.20170—
+7K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+7K171444YUKON OCT Spinal SystemK2m, Inc.2017133