510(k) Report

Devices descending from K082236

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+6K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+6K213876Spineology Navigation InstrumentsSpineology, Inc.20221—
+6K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+6K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+6K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+6K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+6K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+6K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+6K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+6K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+6K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+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—
+6K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+6K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+6K201569CUVIS-spineCurexo, Inc.20212—
+6K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+6K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+6K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+6K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+6K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+6K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+6K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+6K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+6K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+6K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+6K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+6K201585Monterey AL Interbody SystemStryker Corporation202044
+6K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+6K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+6K200896Solstice CCILife Spine, Inc.20200—
+6K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+6K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+6K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+6K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+6K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+6K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+6K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+6K191217Jazz PFImplanet, S.A.20190—
+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—
+6K181188EVEREST Spinal SystemK2m, Inc.20186—
+6K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+6K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+6K171570Additional VIPER PRIME™ screws with fenestrationsMedos International SARL201720—
+6K171881JAZZ Passer BandImplanet, S.A.20170—
+6K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+6K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+6K170647Connector SystemOrthofix, Inc.201718—
+6K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+6K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+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
+7K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+7K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+7K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+7K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+7K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+7K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+7K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+7K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+7K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+7K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+7K260038E3D™-C Interbody SystemEvolution Spine20261—
+7K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+7K251943Spineology Navigation InstrumentsSpineology, Inc.20250—
+7K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+7K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+7K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+7K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+7K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+7K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+7K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+7K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+7K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+7K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+7K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+7K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+7K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+7K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+7K242042TriALTIS™ Spine SystemMedos International SARL20241—
+7K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+7K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+7K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+7K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+7K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+7K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+7K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+7K233256Robotic Integration InstrumentsDePuy Synthes20240—
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+7K240526POWEReam Xia/SerratoStryker Instruments20240—
+7K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+7K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—