510(k) Report

Devices descending from K020887

1,622 later devices reach Ebi Ais Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K131077Life Spine Plateau Spacer SystemLife Spine201310—
+5K131671MectalifMedacta International201322—
+5K130699Aleutian Spinal SystemK2m, Inc.2013570—
+5K122801Providence Cervical CageProvidence Medical Technology, Inc.20131—
+5K130506Imse P-TlifInstitute of Musculoskeletal Science & Education20130—
+5K130306Incite Anchored Cervical Interbody DeviceIncite Innovation, LLC20131—
+5K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+5K123767Lanx Fusion System- SALanx, Inc.20133244
+5K123993Solus Anterior Lumbar Interbody Fusion (Alif) SystemAlphatec Spine, Inc.20130—
+5K122872Intervertebral Body Fusion DeviceDio Medical Co., Ltd.201316—
+5K120603Varilift -CWenzel Spine2013193—
+5K121254Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies201340—
+5K121649Construx Mini Peek TI Spacer SystemOrthofix2012289—
+5K123207Primalif TM Llif Unitary Peek Lateral Lumbar Interbody Fusion SystemOsteomed LP201216—
+5K121151Pro-Link Cervical Spacer SystemLife Spine, Inc.2012116—
+5K122956Fuselox Lumbar Interbody Fusion DeviceCaptiva Spine20122—
+5K122021Sterispine LC CageSafe Orthopaedics20122—
+5K120819Stalif CCentinel Spine, Inc.2012206—
+5K122444Cervical CageEisertech, LLC201222—
+5K120275Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC2012173—
+5K120396Reliance Cervical Ibf SystemReliance Medical Systems, LLC201225—
+5K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+5K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc.2012761—
+5K120031Chesapeake Spinal SystemK2m, Inc.2012334—
+5K112862Mecta-CMedacta International201114—
+5K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011324—
+5K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331—
+5K100967Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2011121—
+5K111675VU C*Pod Intervertebral Body Fusion DeviceTheken Spine, LLC201162—
+5K103111Forza Spacer SystemOrthofix, Inc.20113431
+5K103169AleuttianK2m, Inc.2011572—
+5K102322Stingray Cervical Cage; Shark Implant (Plif); Bull Shark Implant (Plif); Tiger Implant…Omni Surgical, L.P.20116—
+5K100037Advanced Vertebral Solutions Express BFDAdvanced Vertebral Solutions, LLC20100—
+5K100210TRANS1 Lateral Intervertebral Fusion Device, TTrans1 Incorporated2010175—
+5K100820Wenzel Spine Varilift Interbody Fusion SystemWenzel Spine201016—
+5K100544Impix Lumbar Interbody DeviceMedicrea Technologies201001
+5K101302Aleutian Ibf SystemK2m, Inc.2010595—
+5K100043Coroent XLR Standalone SystemNuvasive, Inc.2010744—
+5K091301Life Spine Stand-Alone Spacer SystemLife Spine2009473—
+5K080401Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG2008840—
+5K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.20081,103—
+5K080083Intrepid Spinal SystemMedtronic Sofamor Danek20089328
+5K073502Vertebron VBR SystemVertebron, Inc.200812—
+6K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+6K261049Scala® TLSpineart SA20260—
+6K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+6K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+6K2530413d Cage CervicalFims Co., Ltd.20260—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—
+6K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+6K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+6K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+6K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+6K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+6K261067BEE PLIF CageNGMedical GmbH20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K252774Uni-C Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+6K242303MOD-COrthomod, LLC20260—
+6K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+6K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+6K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+6K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+6K253545Vulcan Spinal SystemK2m, Inc.20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K253158VyBrate™ VBR SystemVy Spine, LLC20260—
+6K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+6K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+6K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+6K250769Dakota LP SystemPrecision Spine, Inc.20250—
+6K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+6K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+6K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+6K251016MectaLIF 3D MetalMedacta International S.A.20250—
+6K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+6K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+6K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+6K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+6K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+6K250186GoLIF! Lumbar Interbody Fusion SystemGetset Surgical, SA20250—
+6K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+6K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+6K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+6K243670Idys® LIFClariance20240—
+6K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+6K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+6K242267Gemini Medical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+6K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+6K242457EARP Interbody SystemRetropsoas Technologies, LLC20240—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+6K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+6K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+6K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+6K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+6K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+6K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+6K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—