510(k) Report

Devices descending from K173115

83 later devices reach COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+1K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+1K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+1K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+1K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+1K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+1K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+1K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+1K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+1K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+1K190885Elevation Spine Saber-C SystemElevation Spine201925—
+1K180909REVEL SpacersGlobus Medical, Inc.201837—
+2K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+2K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+2K260660SABER-C SystemElevation Spine20261—
+2K253260ORIO-3D Cage SystemSpineCraft20260—
+2K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+2K250769Dakota LP SystemPrecision Spine, Inc.20250—
+2K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+2K250540SABER-C SystemElevation Spine20252—
+2K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+2K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+2K241846E3D™-C Interbody SystemEvolution Spine20246—
+2K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+2K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+2K230329F3D Interbody SystemCorelink, LLC20230—
+2K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+2K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+2K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+2K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+2K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+2K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+2K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+2K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+3K263049SABER-C SystemElevation Spine20260—
+3K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+3K262094E3D™-C Interbody SystemEvolution Spine20260—
+3K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+3K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+3K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+3K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+3K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+3K260038E3D™-C Interbody SystemEvolution Spine20261—
+3K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+3K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+3K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+3K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+3K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+3K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+3K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+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—
+3K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+3K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+3K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+3K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+3K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+3K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+3K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+3K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+3K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+3K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+3K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+4K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+4K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+4K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+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—
+4K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+4K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+4K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+4K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+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—
+4K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+4K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+5K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+5K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+5K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+5K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—