510(k) Report

Devices descending from K083389

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+1K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+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—
+1K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+1K132999Cervical Stand Alone SystemOrthofix, Inc.2014281—
+1K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+1K131951Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.201312—
+1K131449Coalition SpacerGlobus Medical, Inc.2013235—
+1K130478Sustain and Sustain Radiolucent SpacersGlobus Medical, Inc.2013256—
+1K122771Spinal Elements Cervical Intervertebral Body Fusion SystemSpinal Elements, Inc.2013147—
+1K122630IN:C2 Spinal Fixation SystemSpine Smith Partners L.P.2012405—
+1K121151Pro-Link Cervical Spacer SystemLife Spine, Inc.2012116—
+1K121569Matisse Anterior Cervical Interbody Fusion Cage SystemAccel Spine20123—
+1K120840Lexus Cervical Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201214—
+1K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+1K112388Lanx Cervical SALanx, Inc.201126—
+1K112068Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp2011331
+1K111439Chesapeake (Cervical Components)K2m, Inc.20113451
+1K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+1K102323Cervical Standalone Intervertebral Body Fusion DeviceTheken Spine, LLC201062—
+2K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+2K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+2K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+2K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+2K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+2K250769Dakota LP SystemPrecision Spine, Inc.20250—
+2K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+2K241846E3D™-C Interbody SystemEvolution Spine20246—
+2K240715Idys® C ZP 3DTiClariance20240—
+2K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+2K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+2K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+2K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+2K220334MONET Anterior Cervical Plate SystemCtl Medical Corporation20220—
+2K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+2K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+2K212562Idys-C ZP 3DTiClariance, SA20211—
+2K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+2K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+2K201287Impulse Interbody Fusion SystemDegen Medical20208—
+2K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+2K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+2K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+2K190885Elevation Spine Saber-C SystemElevation Spine201925—
+2K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+2K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+2K180909REVEL SpacersGlobus Medical, Inc.201837—
+2K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+2K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+2K172788MONET™ Anterior Cervical Interbody Fusion Cage SystemCtl Medical Corporation20181—
+2K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+2K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+2K172212MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™Ctl Medical Corporation20181—
+2K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+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—
+2K172424Velofix™ SA Cervical CageU&I Corporation201751
+2K173080IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)Huvexel Co., Ltd.20172—
+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—
+2K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+2K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+2K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+2K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201683—
+2K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+2K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+2K152622Alta ACDF SystemBiomet Spine20160—
+2K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies201632—
+2K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+2K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+2K152515TOMCAT Cervical Spinal SystemChoicespine, LP2015108—
+2K151934ROI-C Titanium-Coated Implant SystemLdr Spine USA20159—
+2K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+2K142487Chesapeake Stabilization SystemK2m, Inc.201571
+2K143360LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20159—
+2K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+2K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc.2015280—
+2K133218Crystal ®; Mosaic ®; Vertu ®Spinal Elements, Inc.2014130—
+2K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+2K141537IN:C2 Spinal Fixation SystmeSpine Smith Holdings, LLC20140—
+2K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+2K141005Z-Link CervicalZavation, LLC20144—
+2K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+2K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424—
+2K131350Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.2013214
+2K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+2K121852Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp201230—
+3K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+3K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+3K262094E3D™-C Interbody SystemEvolution Spine20260—
+3K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+3K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+3K260660SABER-C SystemElevation Spine20261—
+3K253260ORIO-3D Cage SystemSpineCraft20260—
+3K242303MOD-COrthomod, LLC20260—
+3K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—