510(k) Report

Devices descending from K191391

84 later devices reach HEDRON Lumbar Spacers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253260ORIO-3D Cage SystemSpineCraft20260—
+1K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+1K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+1K240368E3D™-A Interbody SystemEvolution Spine20247—
+1K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+1K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+1K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+1K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+1K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+1K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+1K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+1K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+1K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+1K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+1K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+1K201671A-Link ZAcuity Surgical Devices, LLC202125—
+1K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+1K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+1K201087CORBEL SpacersGlobus Medical, Inc.202036—
+2K261408SABER-XA SystemElevation Spine20260—
+2K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+2K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+2K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+2K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+2K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+2K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+2K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+2K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+2K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+2K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+2K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+2K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+2K241846E3D™-C Interbody SystemEvolution Spine20246—
+2K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+2K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+2K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+2K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+2K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+2K232432E3D™-A Interbody SystemEvolution Spine20248—
+2K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+2K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+2K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+2K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+2K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+2K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+2K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+2K222561AlignAcuity Surgical Devices, LLC202214—
+2K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+2K220610SOLO-LAurora Spine, Inc.20220—
+2K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+2K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+3K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+3K262094E3D™-C Interbody SystemEvolution Spine20260—
+3K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+3K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+3K260038E3D™-C Interbody SystemEvolution Spine20261—
+3K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+3K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+3K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+3K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+3K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+3K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+3K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+3K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+3K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+3K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+3K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+3K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+3K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+3K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+3K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+3K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+3K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+4K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+4K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+4K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+4K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+4K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+4K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+4K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+4K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+4K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+5K261279DeltaNEC Interbody SystemNexus Spine20260—
+5K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—