510(k) Report

Devices descending from K131449

235 later devices reach Coalition Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+1K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+1K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+1K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+1K151939COALITION SpacersGlobus Medical, Inc.2016152—
+1K141005Z-Link CervicalZavation, LLC20144—
+2K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+2K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+2K241846E3D™-C Interbody SystemEvolution Spine20246—
+2K231808QUASAR Standalone ACIF SystemGS Medical Co., Ltd.20230—
+2K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+2K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+2K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+2K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+2K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+2K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+2K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+2K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+2K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+2K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+2K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+2K170569SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201782—
+2K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201683—
+2K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+2K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+3K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+3K262094E3D™-C Interbody SystemEvolution Spine20260—
+3K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+3K242303MOD-COrthomod, LLC20260—
+3K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+3K260038E3D™-C Interbody SystemEvolution Spine20261—
+3K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+3K250560BEE HANGMedical GmbH20250—
+3K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+3K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+3K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+3K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+3K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+3K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+3K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+3K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+3K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+3K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+3K212612Omnia Medical TiBrid-SCOmnia Medical, LLC20220—
+3K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+3K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+3K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+3K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+3K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+3K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+3K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+3K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+3K203444BEE HA CageNGMedical GmbH20211—
+3K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+3K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+3K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+3K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+3K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+3K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+3K201585Monterey AL Interbody SystemStryker Corporation202044
+3K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+3K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+3K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+3K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+3K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+3K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+3K190885Elevation Spine Saber-C SystemElevation Spine201925—
+3K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+3K190655SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201974—
+3K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+3K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+3K180909REVEL SpacersGlobus Medical, Inc.201837—
+3K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+4K261049Scala® TLSpineart SA20260—
+4K261408SABER-XA SystemElevation Spine20260—
+4K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+4K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+4K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+4K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+4K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+4K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+4K260660SABER-C SystemElevation Spine20261—
+4K253260ORIO-3D Cage SystemSpineCraft20260—
+4K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+4K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+4K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+4K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+4K250769Dakota LP SystemPrecision Spine, Inc.20250—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+4K250540SABER-C SystemElevation Spine20252—
+4K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+4K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+4K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+4K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+4K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+4K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+4K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+4K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—