510(k) Report

Devices descending from K093669

744 later devices reach Sec Ibf Cage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+4K261049Scala® TLSpineart SA20260—
+4K261430TruLift Expandable SystemLife Spine, Inc.20260—
+4K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+4K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+4K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+4K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+4K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+4K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+4K250560BEE HANGMedical GmbH20250—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+4K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+4K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+4K241525ExcelsiusXR™Globus Medical, Inc.20250—
+4K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+4K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—
+4K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+4K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+4K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+4K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+4K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+4K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+4K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+4K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+4K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+4K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+4K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+4K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+4K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+4K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+4K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K230329F3D Interbody SystemCorelink, LLC20230—
+4K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+4K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+4K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+4K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+4K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+4K213417Ghost Spacer SystemLife Spine, Inc.20220—
+4K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+4K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+4K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+4K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+4K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+4K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+4K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+4K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+4K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+4K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+4K211740DualXAmplify Surgical, Inc.20211—
+4K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+4K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+4K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+4K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+4K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+4K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+4K210728CONDUIT InstrumentsMedos International SARL20215—
+4K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+4K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+4K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+4K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+4K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+4K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+4K200316UNiD IB3D ALIFMedicrea International SA20200—
+4K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+4K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+4K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+4K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+4K193521Steerable Plateau TiLife Spine, Inc.20201—
+4K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+4K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+4K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+4K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+4K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+4K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+4K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+4K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+4K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+4K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+4K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+4K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+4K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+5K261408SABER-XA SystemElevation Spine20260—
+5K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+5K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+5K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+5K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+5K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+5K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+5K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+5K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+5K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+5K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—