510(k) Report

Devices descending from K010530

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K081636Peek-Optima Alif SpacerBiomet Spine2008542—
+3K081395Solitaire Peek-Optima Anterior Spinal SystemBiomet Spine2008854—
+3K080673Interfuse Intervertebral Body Fusion DeviceVertebral Technologies, Inc.2008103—
+3K073177Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology20087751
+3K080083Intrepid Spinal SystemMedtronic Sofamor Danek20089328
+3K073470Avs PL Peek Spacers, Models 48351XXX and 48353XXXStryker Spine20081,102—
+3K072981Synthes Zero-PSynthes Spine Co.Lp20085462
+3K071274Gso GS1 SpacerGold Standard Orthopedics, LLC20070—
+3K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.20071,406—
+3K052384Lanx VBR SystemLanx, LLC2005455—
+3K050449Quantum Vertebral Body ReplacementQuantum Orthopedics, Inc.2005197—
+3K043479MC+ Partial VBRLdr Spine USA20051,214—
+3K043349Open Radiotransparent Intersomatic Implant (Roi)Ldr Spine USA2005134—
+3K043405Nuvasive Coroent SystemNuvasive, Inc.20057121
+3K043206Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer)Pioneer Surgical Technology20051,571—
+3K042714Fidji-Vertebral Body Replacement Type 1, 2, 3 and 4Spine Next America Corporation2004838—
+3K042930Spacevision Cage SystemSpine Vision, Inc.20041,440—
+3K040731Stryker Spine Vertebral SpacerStryker Spine2004895—
+4K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+4K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+4K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+4K251016MectaLIF 3D MetalMedacta International S.A.20250—
+4K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+4K251741PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20250—
+4K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+4K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+4K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+4K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+4K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+4K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+4K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+4K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+4K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+4K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+4K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+4K231359RODIN™ Expandable Lumbar Cage SystemCtl Medical Corporation20230—
+4K223430ProLift Micro Expandable Spacer SystemLife Spine, Inc.20236—
+4K230808PEEK SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20230—
+4K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+4K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+4K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+4K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+4K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+4K221172FOCUS Interbody SystemOc Medical Devices20220—
+4K222797X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20221—
+4K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+4K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+4K220655X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20222—
+4K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+4K210573Velofix SA Cervical CageU&I Corporation20211—
+4K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC20210—
+4K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+4K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+4K203802X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20213—
+4K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+4K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+4K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+4K201287Impulse Interbody Fusion SystemDegen Medical20208—
+4K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+4K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+4K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+4K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+4K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+4K201585Monterey AL Interbody SystemStryker Corporation202044
+4K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+4K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+4K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+4K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+4K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+4K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+4K192906Mecta-C Stand AloneMedacta International S.A.20201—
+4K193320KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20203—
+4K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+4K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+4K190721LongBow TiLife Spine, Inc.20190—
+4K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+4K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+4K183407Triton CageMedyssey USA, Inc.20190—
+4K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+4K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+4K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+4K190488ProLift Expandable SystemLife Spine, Inc.201916—
+4K190680Favo S-TlifSilony Medical GmbH20190—
+4K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+4K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+4K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+4K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+4K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+4K182470Plateau Spacer SystemLife Spine20180—
+4K182322Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+4K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+4K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+4K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+4K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+4K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+4K181337Sypher Spacer SystemBiogennix, LLC20180—
+4K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar SystemLife Spine, Inc.20182—
+4K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+4K181380LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201810—