510(k) Report

Devices descending from K110270

743 later devices reach Acculif Cage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113465Acculif TL CageCoalign Innovations, Inc.2011718—
+1K112095Acculif TL-Peek Ibf CageCoalign Innovations, Inc.2011319—
+2K193457AUDERE Lumbar Spacer SystemMet One Technologies20201—
+2K173518Spectrum Spine Expandable Cages (SSEC)Spectrum Spine, LLC20196—
+2K172480icotec Interbody Cage SystemIcotec AG20185—
+2K171914Cortina™ Lumbar Cage SystemNeurostructures, Inc.20172—
+2K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+2K162693VertebraLINK Fusion PlatformFacetlink Dba Linkspine20170—
+2K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+2K142023Luna Interbody SystemBenvenue Medical, Inc.20145—
+2K133813Flxfit Intervertebral Body Fusion DeviceExpanding Orthopedics, Inc.2014137—
+2K140411Altera SpacerGlobus Medical, Inc.201419122
+2K123607Octane Elevate Spinal Implant SystemExactech, Inc.20141—
+2K130194Acculif XL CageCoalign Innovations, Inc.20131—
+2K123281Acculif TL-Peek CageCoalign Innovations, Inc.2013146—
+2K123752Acculif TL and PL CageCoalign Innovations, Inc.2013676—
+2K121683Acculif TL CageCoalign Innovations, Inc.2012682—
+3K2530413d Cage CervicalFims Co., Ltd.20260—
+3K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+3K261067BEE PLIF CageNGMedical GmbH20260—
+3K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+3K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+3K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+3K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+3K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+3K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+3K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+3K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+3K211413BEE PLIF CageNGMedical GmbH20211—
+3K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+3K200429BEE CagesNGMedical GmbH202111—
+3K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+3K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+3K200312Tryptik TiSpineart20202—
+3K192897icotec Cervical CageIcotec AG20201—
+3K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+3K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+3K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+3K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+3K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+3K1803473d CageFims Co., Ltd.20190—
+3K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+3K183092Kuros TLIF CageKuros Biosciences B.V20190—
+3K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+3K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+3K181397DualXInnovasive, Inc.201815—
+3K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+3K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+3K180431Cortina [MAX] Lumbar Cage SystemNeurostructures, Inc.20181—
+3K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+3K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+3K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+3K171519FLXfit™Expanding Orthopedics, Inc.2017711
+3K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+3K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+3K153400ProLift Expandable SystemLife Spine, Inc.201672—
+3K132505Acculif TL and PL CageCoalign Innovations, Inc.20136453
+3K131443Coalign Innovations Acculif XL Ibf CageCoalign Innovations, Inc.20130—
+4K261049Scala® TLSpineart SA20260—
+4K261430TruLift Expandable SystemLife Spine, Inc.20260—
+4K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+4K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+4K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+4K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+4K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+4K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+4K241525ExcelsiusXR™Globus Medical, Inc.20250—
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+4K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+4K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+4K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+4K240699SCARLET® AC-TiSpineart SA20240—
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+4K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+4K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+4K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+4K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+4K222833Ventana™ C Spinal SystemSpinal Elements, Inc.20234—
+4K223430ProLift Micro Expandable Spacer SystemLife Spine, Inc.20236—
+4K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+4K230583Tryptik TiSpineart SA20231—
+4K223065Adcura® Sagittae® Lateral Lumbar Interbody Fusion DevicesAdcura, Inc.20220—
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+4K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+4K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+4K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+4K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+4K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+4K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+4K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+4K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+4K211740DualXAmplify Surgical, Inc.20211—
+4K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+4K211616ExcelsiusHubGlobus Medical, Inc.20219Class I