510(k) Report

Devices descending from K043316

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K1803473d CageFims Co., Ltd.20190—
+4K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+4K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+4K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+4K183092Kuros TLIF CageKuros Biosciences B.V20190—
+4K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+4K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+4K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+4K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+4K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar SystemLife Spine, Inc.20182—
+4K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+4K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+4K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188—
+4K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+4K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+4K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+4K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+4K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+4K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+4K172816TiGer Shark™ SystemChoicespine, LP201859—
+4K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+4K172424Velofix™ SA Cervical CageU&I Corporation201751
+4K172032Modulift Vertebral Body Replacement (VBR) SystemAesculap Implants Systems, Inc.201746—
+4K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies20176—
+4K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+4K171914Cortina™ Lumbar Cage SystemNeurostructures, Inc.20172—
+4K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+4K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+4K170550Coveris Cervical Cage SystemCamber Spine Technologies20171—
+4K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+4K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+4K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+4K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+4K162693VertebraLINK Fusion PlatformFacetlink Dba Linkspine20170—
+4K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+4K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+4K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc.20166—
+4K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education20160—
+4K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+4K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+4K161280Cervical Stand Alone SystemOrthofix, Inc.201614—
+4K160995NEOVIEW Plating SystemIn2bones Sas201624
+4K160154ALTA Anterior Cervical Interbody SpacerAstura Medical201663—
+4K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+4K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+4K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+4K152200SurgTech Interbody SystemSurgtech, Inc.20160—
+4K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+4K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+4K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+4K160291Optimus ALIF SystemAmendia, Inc.20160—
+4K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—
+4K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+4K151496Latitude-C Cervical Interbody Spacer SystemDegen Medical201513—
+4K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+4K150619CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc.2015107—
+4K150847Foundation Interbody DevicesCorelink, LLC201529—
+4K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+4K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+4K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+4K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+4K142744Mecta-C TiPEEKMedacta International201512—
+4K140348Interbody CageEisertech, LLC2015235—
+4K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+4K141333Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.20140—
+4K142150Ais Modulift VBR SystemAesculap Implant System, Inc.201447—
+4K141953Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLTitan Spine, LLC20142652
+4K142589Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS…Titan Spine, LLC2014106—
+4K133717Longbow Spacer SystemLife Spine20149—
+4K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+4K133802Ais Modulift VBR SystemAesculap Implant System, Inc.201448—
+4K132738Cogent Med-LifCogent Spine, LLC201413—
+4K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+4K133967Interbody Cage SystemAurora Spine2014227—
+4K131178Idys Lif CagesClariance201311—
+4K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.201314—
+4K123045Brigade Standalone SystemNuvasive, Inc.2013696—
+4K122872Intervertebral Body Fusion DeviceDio Medical Co., Ltd.201316—
+4K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+4K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…Bm Korea Co., Ltd.20133—
+4K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+4K1217414-Web Cervical STS (Spinal Truss System)4-Web, Inc.201235—
+4K112561Nuvasive Coroent NO-Profile SystemNuvasive, Inc.201212—
+4K111166A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC201123—
+4K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc.2011460—
+4K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+5K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+5K261408SABER-XA SystemElevation Spine20260—
+5K2530413d Cage CervicalFims Co., Ltd.20260—
+5K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+5K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+5K261067BEE PLIF CageNGMedical GmbH20260—
+5K242303MOD-COrthomod, LLC20260—
+5K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+5K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+5K253266Titanium Interbody SystemSpine Innovation, LLC20260—
+5K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—