510(k) Report

Devices descending from K043488

1,128 later devices reach Modification to CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K163011PHA S1 Spinal SystemPhamedica, Inc.20170—
+5K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+5K170543VIPER PRIME™ Screws with FenestrationsMedos International SARL201748—
+5K170108Xultan 5.5 Pedicle Screw SystemMet One Technologies20172—
+5K170964Zenius Spinal SystemMedyssey USA, Inc.20170—
+5K162764Jazz Frame SystemImplanet, S.A.20176—
+5K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+5K162367Erisma® LP MISClariance, Sas20162—
+5K160640PASS XS Spinal SystemMedicrea International SA20160—
+5K161766PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.201618—
+5K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA20163—
+5K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc.20160—
+5K160722CorticaLINK Spinal Fusion PlatformFacetlink Dba Linkspine20162—
+5K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+5K160926F1 MPS Modular Pedicle Screw SystemDegen Medical20161—
+5K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+5K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+5K153413PASS LP Spinal SystemMedicrea International SA20160—
+5K151977icotec Pedicle SystemIcotec AG201630—
+5K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+5K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+5K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+5K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+5K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+5K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201588—
+5K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201584—
+5K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+5K132765PFX Spinous Process Fixation SystemInnovasis, Inc.20140—
+5K140400ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20149—
+5K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+5K130302Spinevision Lumis Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision…Spinevision S.A.20134—
+5K123656Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.201339—
+5K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+5K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011106—
+5K103292Trio Trauma Spinal SystemStryker Corporation201185—
+5K073420Blackstone Ascent Multiaxial ScrewsBlackstone Medical, Inc.20089—
+6K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC20260—
+6K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+6K261408SABER-XA SystemElevation Spine20260—
+6K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+6K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+6K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+6K253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.20260—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+6K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+6K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+6K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+6K251725ANAX™ OCT Spinal SystemCg Medtech Co., Ltd.20250—
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+6K243249TriALTIS™ Spine SystemMedos International SARL20250—
+6K243693NEO Pedicle Screw System™Neo Medical SA20240—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+6K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+6K233256Robotic Integration InstrumentsDePuy Synthes20240—
+6K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+6K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+6K240526POWEReam Xia/SerratoStryker Instruments20240—
+6K233684TriALTIS™ Spine SystemMedos International SARL20234—
+6K231515MySpine Cervical GuidesMedacta International S.A.20230—
+6K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+6K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+6K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+6K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+6K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+6K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+6K223806VERTICALE® Triangular Fixation SystemSilony Medical GmbH20230—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K230762EDEN Spinal Fixation MIS SystemJmt Co., Ltd.20230—
+6K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+6K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+6K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+6K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+6K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+6K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+6K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+6K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+6K222789VADER® Pedicle System, G21 CementIcotec AG202352
+6K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.202220—
+6K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+6K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+6K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+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—
+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—
+6K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+6K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+6K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232