510(k) Report

Devices descending from K092193

647 later devices reach Spinal Usa Interbody Cages through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+1K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+1K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+1K201287Impulse Interbody Fusion SystemDegen Medical20208—
+1K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+1K172480icotec Interbody Cage SystemIcotec AG20185—
+1K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+1K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+1K131082Interform Interbody Cage SystemNext Orthosurgical2013595—
+1K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+1K103369Vault Alif SystemSpinal USA201110—
+2K2530413d Cage CervicalFims Co., Ltd.20260—
+2K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+2K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+2K261067BEE PLIF CageNGMedical GmbH20260—
+2K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+2K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+2K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+2K221172FOCUS Interbody SystemOc Medical Devices20220—
+2K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+2K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+2K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+2K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+2K211413BEE PLIF CageNGMedical GmbH20211—
+2K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+2K200429BEE CagesNGMedical GmbH202111—
+2K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+2K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+2K200312Tryptik TiSpineart20202—
+2K192897icotec Cervical CageIcotec AG20201—
+2K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+2K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+2K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+2K1803473d CageFims Co., Ltd.20190—
+2K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+2K183092Kuros TLIF CageKuros Biosciences B.V20190—
+2K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+2K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+2K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+2K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+2K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+2K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+2K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+2K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+2K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+2K140280ForticoreNanovis, LLC20149—
+2K132596Proposed OptimusCustom Spine, Inc.201451
+2K130445Vault Alif SystemSpinal USA20139—
+3K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+3K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+3K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+3K240699SCARLET® AC-TiSpineart SA20240—
+3K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+3K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+3K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+3K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+3K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+3K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+3K222833Ventana™ C Spinal SystemSpinal Elements, Inc.20234—
+3K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+3K230583Tryptik TiSpineart SA20231—
+3K223418DeGen Impulse AM™ SystemDegen Medical20236—
+3K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+3K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+3K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+3K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+3K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+3K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+3K203444BEE HA CageNGMedical GmbH20211—
+3K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+3K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+3K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+3K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+3K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+3K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+3K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+3K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+3K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+3K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+3K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+3K191134IB3D AlifMedicrea International SA20191—
+3K190680Favo S-TlifSilony Medical GmbH20190—
+3K182608Oyster ACIF CageSilony Medical GmbH20190—
+3K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+3K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+3K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+3K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+3K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+3K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+3K171312FortiCore®Nanovis, LLC20183—
+3K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+3K172009Cascadia Interbody SystemK2m, Inc.2017433
+3K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+3K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+3K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+3K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+3K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+3K161379ELSA SpacersGlobus Medical, Inc.2016155—