510(k) Report

Devices descending from K010530

1,764 later devices reach Geo Structure through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K131425Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale InserterMedtronic Navigation, Inc.201324610
+6K130948C-Fuse Cervical Intervertebral Body Fusion SystemSouthern Spine, LLC201313—
+6K122801Providence Cervical CageProvidence Medical Technology, Inc.20131—
+6K130506Imse P-TlifInstitute of Musculoskeletal Science & Education20130—
+6K130445Vault Alif SystemSpinal USA20139—
+6K130306Incite Anchored Cervical Interbody DeviceIncite Innovation, LLC20131—
+6K123978Capstone L Spinal SystemMedtronic Sofamor Danek USA201313—
+6K122872Intervertebral Body Fusion DeviceDio Medical Co., Ltd.201316—
+6K120603Varilift -CWenzel Spine2013193—
+6K121254Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies201340—
+6K121649Construx Mini Peek TI Spacer SystemOrthofix2012289—
+6K123207Primalif TM Llif Unitary Peek Lateral Lumbar Interbody Fusion SystemOsteomed LP201216—
+6K121151Pro-Link Cervical Spacer SystemLife Spine, Inc.2012116—
+6K122956Fuselox Lumbar Interbody Fusion DeviceCaptiva Spine20122—
+6K122021Sterispine LC CageSafe Orthopaedics20122—
+6K122047Alamo PAlliance Partners, LLC20120—
+6K120819Stalif CCentinel Spine, Inc.2012206—
+6K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2012723—
+6K121211VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2012129—
+6K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc.2012761—
+6K113478Plif CageEisertech, LLC2012269—
+6K113528Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011361—
+6K111983Vista-S Device Model 08/06-401-Xxxxx, 08/06-402-XxxxxxZimmer Trabecular Metal Technology201131—
+6K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011324—
+6K110562Telamon Peek Spinal SystemMedtronic Sofamor Danek USA2011306—
+6K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331—
+6K112756Fortify (TM) and Fortify (TM)-R Corpectomy SpacersGlobus Medical, Inc.2011268—
+6K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011808—
+6K100967Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2011121—
+6K111569Plateau Spacer SystemLife Spine2011181—
+6K110927MectalifMedacta International2011301
+6K110226Interfuse T Invertebral Body Fusion DeviceVertebral Technologies, Inc.201190—
+6K103169AleuttianK2m, Inc.2011572—
+6K100945Fuse Plif CafeAdvanced Medical Technologies AG2011463—
+6K100743Atlas Spine Pivoting SystemAtlas Spine, Inc.20104—
+6K101302Aleutian Ibf SystemK2m, Inc.2010595—
+6K100175Clydesdale Spinal SystemMedtronic Sofamor Danek20101,008—
+6K094025Crescent Spinal SystemMedtronic Sofamor Danek2010838—
+6K090353Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2009796—
+6K091946Vlift-S Vertebral Body Replacement System, Models 488812XX, 488814XX, 488816XX, 488818XXStryker Spine20095—
+6K083311Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc.2009554—
+6K082801Phantom Plus Cage SystemUs Spine2008643—
+6K082732Modification to: Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008710—
+6K082342Modification to Capstone Spinal SystemMedtronic Sofamor Danek2008716—
+6K071983Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-SpaceAesculap Implant Systems, Inc.20087881
+6K070218Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR)Vertiflex (Tm), Incorporated200760—
+7K263049SABER-C SystemElevation Spine20260—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+7K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+7K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+7K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+7K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+7K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+7K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+7K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+7K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+7K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+7K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+7K252774Uni-C Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+7K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+7K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+7K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K253158VyBrate™ VBR SystemVy Spine, LLC20260—
+7K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+7K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+7K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+7K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+7K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+7K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+7K252742Navigated InstrumentsTyber Medical, LLC20251—
+7K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+7K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+7K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+7K253331PressON Spinal Fixation SystemNexus Spine20250—
+7K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+7K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+7K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+7K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K242464Stealth™ Spine Clamps; ModuLeX™ Shank MountsMedtronic Navigation, Inc.20251—
+7K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+7K243474MagnetOs MISKuros Biosciences B.V20250—
+7K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+7K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+7K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+7K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+7K243188Cylox® STSignus Medizintechnik GmbH20250—
+7K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+7K243670Idys® LIFClariance20240—
+7K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+7K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+7K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+7K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+7K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+7K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—