510(k) Report

Devices descending from K170503

199 later devices reach EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K2530413d Cage CervicalFims Co., Ltd.20260—
+1K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+1K261067BEE PLIF CageNGMedical GmbH20260—
+1K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+1K211413BEE PLIF CageNGMedical GmbH20211—
+1K200429BEE CagesNGMedical GmbH202111—
+1K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+1K200312Tryptik TiSpineart20202—
+1K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+1K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+1K1803473d CageFims Co., Ltd.20190—
+1K183092Kuros TLIF CageKuros Biosciences B.V20190—
+1K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+1K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+1K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+1K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+2K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+2K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+2K240699SCARLET® AC-TiSpineart SA20240—
+2K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+2K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+2K222833Ventana™ C Spinal SystemSpinal Elements, Inc.20234—
+2K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+2K230583Tryptik TiSpineart SA20231—
+2K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+2K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+2K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+2K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+2K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+2K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+2K203444BEE HA CageNGMedical GmbH20211—
+2K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+2K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+2K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+2K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+2K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+2K191134IB3D AlifMedicrea International SA20191—
+2K190680Favo S-TlifSilony Medical GmbH20190—
+2K182608Oyster ACIF CageSilony Medical GmbH20190—
+2K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+2K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+2K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+3K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+3K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+3K250560BEE HANGMedical GmbH20250—
+3K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+3K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+3K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+3K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+3K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+3K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+3K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+3K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+3K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+3K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+3K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+3K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+3K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+3K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+3K230329F3D Interbody SystemCorelink, LLC20230—
+3K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+3K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+3K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+3K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+3K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+3K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+3K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+3K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+3K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+3K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+3K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+3K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+3K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+3K210728CONDUIT InstrumentsMedos International SARL20215—
+3K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+3K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+3K200316UNiD IB3D ALIFMedicrea International SA20200—
+3K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+4K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+4K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+4K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+4K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+4K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+4K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+4K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+4K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+4K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+4K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+4K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+4K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+4K250556Porous Biologic ScaffoldVentris Medical20250—
+4K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+4K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+4K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+4K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+4K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+4K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+4K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+4K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+4K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—