510(k) Report

Devices descending from K142218

155 later devices reach Coalition AGX Plate and Coalition AGX Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+1K250769Dakota LP SystemPrecision Spine, Inc.20250—
+1K220334MONET Anterior Cervical Plate SystemCtl Medical Corporation20220—
+1K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+1K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+1K190885Elevation Spine Saber-C SystemElevation Spine201925—
+1K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+1K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+1K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+2K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+2K260660SABER-C SystemElevation Spine20261—
+2K253260ORIO-3D Cage SystemSpineCraft20260—
+2K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+2K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+2K250540SABER-C SystemElevation Spine20252—
+2K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+2K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+2K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+2K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+2K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+2K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+2K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+2K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+2K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+2K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+2K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+2K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+2K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+2K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+2K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+2K180909REVEL SpacersGlobus Medical, Inc.201837—
+2K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+2K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+2K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+3K263049SABER-C SystemElevation Spine20260—
+3K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+3K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+3K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+3K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+3K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+3K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+3K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+3K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+3K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+3K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+3K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+3K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+3K241846E3D™-C Interbody SystemEvolution Spine20246—
+3K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+3K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+3K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+3K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+3K230329F3D Interbody SystemCorelink, LLC20230—
+3K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+3K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+3K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+3K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+3K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+3K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+3K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+4K261049Scala® TLSpineart SA20260—
+4K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+4K262094E3D™-C Interbody SystemEvolution Spine20260—
+4K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+4K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+4K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+4K260038E3D™-C Interbody SystemEvolution Spine20261—
+4K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+4K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+4K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+4K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+4K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+4K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+4K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+4K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+4K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+4K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+4K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+4K240368E3D™-A Interbody SystemEvolution Spine20247—
+4K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+4K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+4K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+4K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+4K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+4K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+4K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+4K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+4K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+4K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+4K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+4K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+4K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+4K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+4K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+4K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+4K201671A-Link ZAcuity Surgical Devices, LLC202125—
+4K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+4K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—