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
+6K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+6K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+6K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+6K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+6K191217Jazz PFImplanet, S.A.20190—
+6K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+6K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—
+6K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+6K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+6K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+6K183168OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.201823—
+6K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+6K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+6K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+6K182240PASS LP Spinal SystemMedicrea International SA20182—
+6K182059Prase MIS Spinal SystemGbs Commonwealth Co., Ltd.20182—
+6K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC20186—
+6K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+6K180655Viking Lumbar Polyaxial Screw SystemPresidio Surgical20180—
+6K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+6K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+6K181188EVEREST Spinal SystemK2m, Inc.20186—
+6K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+6K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc.20185—
+6K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+6K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemSilony Medical GmbH20186—
+6K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+6K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+6K172417SILC® Fixation SystemGlobus Medical, Inc.20171—
+6K172194Connector SystemOrthofix, Inc.2017162
+6K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+6K171881JAZZ Passer BandImplanet, S.A.20170—
+6K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+6K163011PHA S1 Spinal SystemPhamedica, Inc.20170—
+6K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+6K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+6K170108Xultan 5.5 Pedicle Screw SystemMet One Technologies20172—
+6K170964Zenius Spinal SystemMedyssey USA, Inc.20170—
+6K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+6K162367Erisma® LP MISClariance, Sas20162—
+6K161766PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.201618—
+6K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA20163—
+6K160722CorticaLINK Spinal Fusion PlatformFacetlink Dba Linkspine20162—
+6K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+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—
+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—
+7K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+7K253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.20260—
+7K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+7K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+7K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+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—
+7K251943Spineology Navigation InstrumentsSpineology, Inc.20250—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+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—
+7K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+7K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+7K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+7K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+7K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+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—
+7K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+7K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+7K241846E3D™-C Interbody SystemEvolution Spine20246—
+7K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+7K240368E3D™-A Interbody SystemEvolution Spine20247—
+7K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+7K240526POWEReam Xia/SerratoStryker Instruments20240—
+7K232628VADER® Pedicle SystemIcotec AG20241—
+7K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+7K233366SYMPHONY OCT SystemMedos International SARL20230—
+7K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+7K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+7K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+7K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+7K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+7K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—