510(k) Report

Devices descending from K112095

319 later devices reach Acculif TL-Peek Ibf Cage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193457AUDERE Lumbar Spacer SystemMet One Technologies20201—
+1K173518Spectrum Spine Expandable Cages (SSEC)Spectrum Spine, LLC20196—
+1K172480icotec Interbody Cage SystemIcotec AG20185—
+1K171914Cortina™ Lumbar Cage SystemNeurostructures, Inc.20172—
+1K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+1K162693VertebraLINK Fusion PlatformFacetlink Dba Linkspine20170—
+1K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+1K142023Luna Interbody SystemBenvenue Medical, Inc.20145—
+1K133813Flxfit Intervertebral Body Fusion DeviceExpanding Orthopedics, Inc.2014137—
+1K123607Octane Elevate Spinal Implant SystemExactech, Inc.20141—
+1K123281Acculif TL-Peek CageCoalign Innovations, Inc.2013146—
+2K2530413d Cage CervicalFims Co., Ltd.20260—
+2K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+2K261067BEE PLIF CageNGMedical GmbH20260—
+2K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+2K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+2K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+2K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+2K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+2K211413BEE PLIF CageNGMedical GmbH20211—
+2K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+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—
+2K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+2K1803473d CageFims Co., Ltd.20190—
+2K183092Kuros TLIF CageKuros Biosciences B.V20190—
+2K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+2K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+2K181397DualXInnovasive, Inc.201815—
+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—
+2K180431Cortina [MAX] Lumbar Cage SystemNeurostructures, Inc.20181—
+2K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+2K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+2K171519FLXfit™Expanding Orthopedics, Inc.2017711
+2K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+2K153400ProLift Expandable SystemLife Spine, Inc.201672—
+2K131443Coalign Innovations Acculif XL Ibf CageCoalign Innovations, Inc.20130—
+2K130194Acculif XL CageCoalign Innovations, Inc.20131—
+3K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+3K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+3K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+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—
+3K222833Ventana™ C Spinal SystemSpinal Elements, Inc.20234—
+3K223430ProLift Micro Expandable Spacer SystemLife Spine, Inc.20236—
+3K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+3K230583Tryptik TiSpineart SA20231—
+3K223065Adcura® Sagittae® Lateral Lumbar Interbody Fusion DevicesAdcura, Inc.20220—
+3K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+3K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+3K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+3K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+3K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+3K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+3K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+3K211740DualXAmplify Surgical, Inc.20211—
+3K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+3K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+3K203444BEE HA CageNGMedical GmbH20211—
+3K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+3K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+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—
+3K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+3K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+3K191134IB3D AlifMedicrea International SA20191—
+3K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+3K190488ProLift Expandable SystemLife Spine, Inc.201916—
+3K190680Favo S-TlifSilony Medical GmbH20190—
+3K182608Oyster ACIF CageSilony Medical GmbH20190—
+3K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+3K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+3K182470Plateau Spacer SystemLife Spine20180—
+3K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+3K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+3K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+3K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+3K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+3K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+3K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+4K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+4K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+4K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+4K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+4K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+4K250560BEE HANGMedical GmbH20250—
+4K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+4K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—