510(k) Report

Devices descending from K042268

1,620 later devices reach Ebi Cas Spine Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K121254Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies201340—
+4K121649Construx Mini Peek TI Spacer SystemOrthofix2012289—
+4K123207Primalif TM Llif Unitary Peek Lateral Lumbar Interbody Fusion SystemOsteomed LP201216—
+4K121151Pro-Link Cervical Spacer SystemLife Spine, Inc.2012116—
+4K122956Fuselox Lumbar Interbody Fusion DeviceCaptiva Spine20122—
+4K122021Sterispine LC CageSafe Orthopaedics20122—
+4K120819Stalif CCentinel Spine, Inc.2012206—
+4K122444Cervical CageEisertech, LLC201222—
+4K120275Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC2012173—
+4K120396Reliance Cervical Ibf SystemReliance Medical Systems, LLC201225—
+4K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+4K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc.2012761—
+4K120031Chesapeake Spinal SystemK2m, Inc.2012334—
+4K112862Mecta-CMedacta International201114—
+4K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011324—
+4K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331—
+4K100967Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2011121—
+4K111675VU C*Pod Intervertebral Body Fusion DeviceTheken Spine, LLC201162—
+4K103111Forza Spacer SystemOrthofix, Inc.20113431
+4K103169AleuttianK2m, Inc.2011572—
+4K102322Stingray Cervical Cage; Shark Implant (Plif); Bull Shark Implant (Plif); Tiger Implant…Omni Surgical, L.P.20116—
+4K100037Advanced Vertebral Solutions Express BFDAdvanced Vertebral Solutions, LLC20100—
+4K100210TRANS1 Lateral Intervertebral Fusion Device, TTrans1 Incorporated2010175—
+4K100820Wenzel Spine Varilift Interbody Fusion SystemWenzel Spine201016—
+4K100544Impix Lumbar Interbody DeviceMedicrea Technologies201001
+4K101302Aleutian Ibf SystemK2m, Inc.2010595—
+4K100043Coroent XLR Standalone SystemNuvasive, Inc.2010744—
+4K091301Life Spine Stand-Alone Spacer SystemLife Spine2009473—
+4K080401Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG2008840—
+4K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.20081,103—
+4K080083Intrepid Spinal SystemMedtronic Sofamor Danek20089328
+4K073502Vertebron VBR SystemVertebron, Inc.200812—
+5K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+5K261049Scala® TLSpineart SA20260—
+5K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+5K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+5K2530413d Cage CervicalFims Co., Ltd.20260—
+5K262094E3D™-C Interbody SystemEvolution Spine20260—
+5K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+5K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+5K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+5K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+5K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+5K261067BEE PLIF CageNGMedical GmbH20260—
+5K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+5K252774Uni-C Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+5K242303MOD-COrthomod, LLC20260—
+5K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+5K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+5K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+5K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K260038E3D™-C Interbody SystemEvolution Spine20261—
+5K253158VyBrate™ VBR SystemVy Spine, LLC20260—
+5K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+5K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+5K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+5K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+5K250769Dakota LP SystemPrecision Spine, Inc.20250—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+5K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+5K251016MectaLIF 3D MetalMedacta International S.A.20250—
+5K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+5K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+5K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+5K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+5K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+5K250186GoLIF! Lumbar Interbody Fusion SystemGetset Surgical, SA20250—
+5K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+5K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+5K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+5K243670Idys® LIFClariance20240—
+5K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+5K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+5K242267Gemini Medical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+5K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+5K242457EARP Interbody SystemRetropsoas Technologies, LLC20240—
+5K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+5K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+5K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+5K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+5K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+5K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+5K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+5K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+5K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+5K240699SCARLET® AC-TiSpineart SA20240—
+5K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+5K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+5K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+5K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+5K233359DOMINION Expandable Corpectomy SystemAstura Medical20242—
+5K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+5K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+5K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+5K232123MectaLIF Anterior Lag ExtensionMedacta International S.A.20231—
+5K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—