510(k) Report

Devices descending from K151939

152 later devices reach COALITION Spacers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+1K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+1K241846E3D™-C Interbody SystemEvolution Spine20246—
+1K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+1K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+1K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+1K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+1K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+1K170569SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201782—
+1K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201683—
+2K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+2K262094E3D™-C Interbody SystemEvolution Spine20260—
+2K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+2K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+2K260038E3D™-C Interbody SystemEvolution Spine20261—
+2K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+2K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+2K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+2K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+2K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+2K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+2K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+2K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+2K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+2K212612Omnia Medical TiBrid-SCOmnia Medical, LLC20220—
+2K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+2K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+2K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+2K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+2K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+2K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+2K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+2K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+2K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+2K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+2K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+2K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+2K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+2K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+2K190885Elevation Spine Saber-C SystemElevation Spine201925—
+2K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+2K190655SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201974—
+2K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+2K180909REVEL SpacersGlobus Medical, Inc.201837—
+3K261408SABER-XA SystemElevation Spine20260—
+3K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+3K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+3K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+3K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+3K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+3K260660SABER-C SystemElevation Spine20261—
+3K253260ORIO-3D Cage SystemSpineCraft20260—
+3K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+3K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+3K250769Dakota LP SystemPrecision Spine, Inc.20250—
+3K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+3K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+3K250540SABER-C SystemElevation Spine20252—
+3K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+3K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+3K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+3K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+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—
+3K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+3K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+3K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+3K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+3K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+3K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+3K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+3K230329F3D Interbody SystemCorelink, LLC20230—
+3K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+3K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+3K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+3K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+3K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+3K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+3K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+3K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+3K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+3K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+3K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+3K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+3K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+3K201585Monterey AL Interbody SystemStryker Corporation202044
+3K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+4K263049SABER-C SystemElevation Spine20260—
+4K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+4K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+4K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+4K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+4K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+4K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+4K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+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—
+4K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—