510(k) Report

Devices descending from K010530

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K102606Avs Anchor-C Cervical Cage SystemStryker Spine20113841
+5K110177Helena SystemRoyal Oak Medical Devices20110—
+5K103369Vault Alif SystemSpinal USA201110—
+5K103666Lanx LateralLanx, Inc.2011238—
+5K103660Lanx Cervical Intervertebral Body Fusion SystemLanx, Inc.201141—
+5K110045Interfuse DA Invertebral Body Fusion DeviceVertebral Technologies, Inc.20110—
+5K102322Stingray Cervical Cage; Shark Implant (Plif); Bull Shark Implant (Plif); Tiger Implant…Omni Surgical, L.P.20116—
+5K102277Interfuse T Invertebral Body Fusion DeviceVertebral Technologies, Inc.201098—
+5K101812Construx Mini Peek Spacer SystemOrthofix, Inc.2010291—
+5K101301Stalif MidlineCentinel Spine2010474—
+5K100037Advanced Vertebral Solutions Express BFDAdvanced Vertebral Solutions, LLC20100—
+5K101310VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2010480—
+5K101051Avs a-Lat Peek Spacers, Models 48750XXX, 48751XXX, 48752XXX, 48753XXXStryker Spine2010641—
+5K100820Wenzel Spine Varilift Interbody Fusion SystemWenzel Spine201016—
+5K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek2010389—
+5K093864Avs Align Peek Spacers Model 48328XXX, 48326XXXStryker Corp.2010637—
+5K092574Esl Spinal SystemEbi, L.P.2010181—
+5K092774Atlas Intervertebral Body CageSpinal Edge, LLC20100—
+5K092017Pivotec Lumbar Interbody Fusion Device (Lifd)Captiva Spine, Inc.200924—
+5K092336C-Thru Spinal SystemEbi, L.P.2009492—
+5K082698Aleutian Ibf SystemK2m, Inc.2009662—
+5K081880Atlas Spine SpacerAtlas Spine, Inc.20080—
+5K081711Lucent Magnum+Spinal Elements, Inc.20080—
+5K080401Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG2008840—
+5K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.20081,103—
+5K073502Vertebron VBR SystemVertebron, Inc.200812—
+5K071497Atlas Spine Vertebral Body ReplacementAtlas Spine, Inc.20070—
+5K063399Aleutian Spacer SystemK2m, Inc.2007663—
+5K060762Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc.2006789—
+5K062132Avs PL Peek Spacer SystemStryker Spine2006243—
+5K061836Avs Asl Peek Spacer SystemStryker Spine2006213—
+5K060506Stryker Spine Vlift Vertebral Body Replacement SystemStryker Spine2006270—
+5K060350Construx PL/TL Peek Partial VBR SystemBlackstone Medical, Inc.2006754—
+5K053508Synfix-LRSynthes Spine Co.Lp2006391
+6K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+6K2530413d Cage CervicalFims Co., Ltd.20260—
+6K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+6K261279DeltaNEC Interbody SystemNexus Spine20260—
+6K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+6K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+6K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+6K261067BEE PLIF CageNGMedical GmbH20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K253260ORIO-3D Cage SystemSpineCraft20260—
+6K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+6K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+6K253545Vulcan Spinal SystemK2m, Inc.20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K252219Cervical Interbody and VBR Fusion SystemSync Surgical20260—
+6K253266Titanium Interbody SystemSpine Innovation, LLC20260—
+6K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+6K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+6K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+6K250769Dakota LP SystemPrecision Spine, Inc.20250—
+6K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+6K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+6K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+6K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+6K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+6K241525ExcelsiusXR™Globus Medical, Inc.20250—
+6K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+6K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+6K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+6K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+6K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+6K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+6K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+6K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+6K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+6K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+6K250556Porous Biologic ScaffoldVentris Medical20250—
+6K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+6K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+6K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+6K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+6K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+6K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+6K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+6K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K2316554CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd.20240—
+6K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+6K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+6K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+6K242589Scarlet® AL-TSpineart SA20240—
+6K242267Gemini Medical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+6K242457EARP Interbody SystemRetropsoas Technologies, LLC20240—
+6K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+6K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+6K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+6K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+6K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+6K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+6K241846E3D™-C Interbody SystemEvolution Spine20246—