510(k) Report

Devices descending from K030744

1,040 later devices reach Blackstone Surgical Titanium Mesh through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K101288Staxx XD SystemSpine Wave, Inc.201051
+4K100802Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc.2010461—
+4K052210Nuvasive Coroent Extensure SystemNuvasive, Inc.2005263—
+4K051454Aleutian Spacer SystemK2m, LLC2005666—
+5K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+5K261408SABER-XA SystemElevation Spine20260—
+5K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+5K242303MOD-COrthomod, LLC20260—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+5K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+5K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+5K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+5K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+5K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+5K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+5K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+5K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+5K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+5K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+5K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+5K230329F3D Interbody SystemCorelink, LLC20230—
+5K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+5K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+5K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+5K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+5K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+5K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+5K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+5K223251Hexanium PLIFSpinevision, S.A.S.20220—
+5K223510Matrix HA Fusion Porous Cervical IBF SystemInnovasis, Inc.20220—
+5K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+5K221578Hexanium ACIFSpinevision, S.A.S.20224—
+5K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+5K222561AlignAcuity Surgical Devices, LLC202214—
+5K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.20224—
+5K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+5K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+5K220610SOLO-LAurora Spine, Inc.20220—
+5K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+5K213441PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20222—
+5K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+5K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+5K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+5K210573Velofix SA Cervical CageU&I Corporation20211—
+5K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+5K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC20210—
+5K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+5K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+5K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+5K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+5K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+5K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+5K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+5K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+5K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+5K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+5K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+5K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+5K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+5K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+5K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+5K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+5K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+5K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+5K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+5K201087CORBEL SpacersGlobus Medical, Inc.202036—
+5K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+5K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+5K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+5K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+5K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+5K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+5K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+5K190721LongBow TiLife Spine, Inc.20190—
+5K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+5K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+5K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+5K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+5K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+5K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+5K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+5K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+5K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+5K180695FBC 921 (Alif)Fbc Device Aps20180—
+5K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+5K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+5K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+5K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+5K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+5K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+5K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+5K163595IMPIX 3D Print CagesMedicrea International SA2017282
+5K172083Idys™ ALIF SystemClariance, Sas20177—
+5K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+5K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+5K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+5K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+5K170919The TiBow Expandable Spacer SystemLife Spine, Inc.20171—