510(k) Report

Devices descending from K050079

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—
+8K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+8K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+8K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+8K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+8K260038E3D™-C Interbody SystemEvolution Spine20261—
+8K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+8K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+8K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+8K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+8K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+8K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+8K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+8K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+8K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+8K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+8K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+8K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+8K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+8K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+8K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+8K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+8K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+8K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K243249TriALTIS™ Spine SystemMedos International SARL20250—
+8K243693NEO Pedicle Screw System™Neo Medical SA20240—
+8K240160EGPS Navigated InstrumentsAstura Medical20240—
+8K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+8K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+8K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+8K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+8K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+8K240526POWEReam Xia/SerratoStryker Instruments20240—
+8K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+8K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+8K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+8K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+8K233684TriALTIS™ Spine SystemMedos International SARL20234—
+8K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+8K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+8K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+8K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+8K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+8K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+8K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+8K231658VEOS Spinal Fixation SystemSpineway20230—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K223558CUVIS-spineCurexo, Inc.20230—
+8K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+8K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+8K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+8K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+8K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+8K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+8K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+8K213876Spineology Navigation InstrumentsSpineology, Inc.20221—
+8K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+8K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+8K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+8K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+8K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+8K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+8K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+8K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+8K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+8K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+8K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+8K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+8K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+8K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+8K201569CUVIS-spineCurexo, Inc.20212—
+8K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+8K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+8K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+8K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+8K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+8K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+8K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+8K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+8K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+8K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+8K200896Solstice CCILife Spine, Inc.20200—
+8K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+8K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+8K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+8K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+8K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+8K191217Jazz PFImplanet, S.A.20190—
+8K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+8K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+8K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+8K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—