510(k) Report

Devices descending from K043316

1,005 later devices reach Rabea Spinal Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC20193—
+5K183407Triton CageMedyssey USA, Inc.20190—
+5K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+5K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+5K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+5K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+5K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+5K183259Idys™ TLIF TiVacClariance, Sas20191—
+5K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+5K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+5K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+5K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+5K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+5K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+5K183071VLIFT-s Vertebral Body Replacement SystemStryker Spine20194—
+5K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+5K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+5K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+5K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+5K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+5K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+5K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+5K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201828—
+5K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+5K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+5K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+5K180673Normandy VBR SystemZavation Medical Products, LLC20187—
+5K180695FBC 921 (Alif)Fbc Device Aps20180—
+5K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+5K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+5K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+5K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+5K173128Alamo® CAlliance Partners, LLC20182—
+5K180431Cortina [MAX] Lumbar Cage SystemNeurostructures, Inc.20181—
+5K173324ALTA Anterior Cervical Interbody SpacerAstura Medical201827—
+5K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC20181052
+5K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+5K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+5K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+5K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+5K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+5K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+5K172419Velofix™ TLIF CageU&I Corporation20172—
+5K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+5K163595IMPIX 3D Print CagesMedicrea International SA2017282
+5K172083Idys™ ALIF SystemClariance, Sas20177—
+5K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+5K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+5K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+5K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—
+5K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+5K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+5K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+5K170919The TiBow Expandable Spacer SystemLife Spine, Inc.20171—
+5K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+5K163589SIGN IM NailSign Fracture Care International20170—
+5K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+5K163506Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar…Vertera, Inc.2017224—
+5K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+5K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+5K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+5K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+5K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+5K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC2017143—
+5K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+5K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+5K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+5K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+5K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+5K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+5K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+5K153665Prow Fusion-LNlt Spine, Ltd.20160—
+5K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+5K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+5K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+5K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+5K152622Alta ACDF SystemBiomet Spine20160—
+5K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+5K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+5K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies201632—
+5K151406Cogent Lateral Interbody SystemCogent Spine, LLC201611—
+5K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+5K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+5K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+5K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+5K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+5K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+5K142487Chesapeake Stabilization SystemK2m, Inc.201571
+5K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+5K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+5K141942Midline II TICentinel Spine, Inc.2014459—
+5K142193Cogent Med-Lif XLCogent Spine, LLC201412—
+5K1421124WEB Spinal Implant Products4Web, Inc.201433—
+5K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+5K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+5K133340Spineworks Anterior Lumbar DeviceSpineworks, LLC201413—
+5K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+5K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+5K121693A-Wedge Anterior Interbody System (a-Wedge Ais)Sapphire Medical Group, Inc.201221—
+6K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—