510(k) Report

Devices descending from K050809

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+6K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+6K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+6K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+6K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+6K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+6K232432E3D™-A Interbody SystemEvolution Spine20248—
+6K233300POWEReam 1/4 DriveStryker Instruments20231—
+6K233684TriALTIS™ Spine SystemMedos International SARL20234—
+6K231515MySpine Cervical GuidesMedacta International S.A.20230—
+6K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+6K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+6K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+6K233366SYMPHONY OCT SystemMedos International SARL20230—
+6K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+6K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+6K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+6K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+6K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+6K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+6K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+6K221307Edge Upper Cervical SystemSpinal Simplicity, LLC20230—
+6K223558CUVIS-spineCurexo, Inc.20230—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+6K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+6K230614Cortium™Ulrich Medical USA20230—
+6K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+6K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+6K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+6K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+6K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+6K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+6K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+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—
+6K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+6K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+6K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+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—
+6K213876Spineology Navigation InstrumentsSpineology, Inc.20221—
+6K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+6K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+6K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+6K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+6K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+6K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+6K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+6K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+6K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+6K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+6K211740DualXAmplify Surgical, Inc.20211—
+6K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+6K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+6K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+6K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+6K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+6K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+6K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+6K201569CUVIS-spineCurexo, Inc.20212—
+6K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+6K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+6K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+6K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+6K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+6K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+6K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+6K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+6K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+6K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+6K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+6K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+6K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+6K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+6K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+6K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+6K200896Solstice CCILife Spine, Inc.20200—
+6K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+6K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+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—
+6K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+6K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+6K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+6K182182YUKON OCT Spinal SystemK2m20185—
+6K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+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—
+6K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+6K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+6K171570Additional VIPER PRIME™ screws with fenestrationsMedos International SARL201720—
+6K171444YUKON OCT Spinal SystemK2m, Inc.2017133