510(k) Report

Devices descending from K120275

173 later devices reach Synthes Acis/Vertebral Spacer CR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+1K212266FIX-C PEEK Anterior Cervical Interbody SystemJeil Medical Corporation20217—
+1K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+1K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+1K181140Axis Chena Cervical PEEK Spacer SystemAxis Orthopaedics20182—
+1K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+1K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+1K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+1K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+1K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+1K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+1K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+2K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+2K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+2K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+2K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+2K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+2K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+2K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+2K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+2K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+2K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+2K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+2K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+2K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+2K201769Cavetto [MAX] Cervical Cage SystemNeurostructures, Inc.20200—
+2K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+2K1920444CIS Marlin PEEK ACIF CageSolco Biomedical Co., Ltd.20190—
+2K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+2K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+2K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+2K181590Neurostructures Cavetto® [MAX] Cervical Cage SystemNeurostructures, Inc.20180—
+2K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+2K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+2K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+3K261049Scala® TLSpineart SA20260—
+3K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+3K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+3K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+3K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+3K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+3K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+3K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+3K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+3K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+3K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+3K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+3K230583Tryptik TiSpineart SA20231—
+3K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+3K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+3K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+3K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+3K192897icotec Cervical CageIcotec AG20201—
+3K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+3K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+3K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+4K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+4K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+4K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+4K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+4K241846E3D™-C Interbody SystemEvolution Spine20246—
+4K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+4K240699SCARLET® AC-TiSpineart SA20240—
+4K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+4K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+4K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+4K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+4K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+4K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+4K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+4K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+5K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+5K262094E3D™-C Interbody SystemEvolution Spine20260—
+5K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+5K260038E3D™-C Interbody SystemEvolution Spine20261—
+5K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+5K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+5K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+5K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+5K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+5K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+5K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+5K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+5K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+5K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+5K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+5K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+5K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+5K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+5K203003Pantheon IBFDPantheon Spinal20210—
+5K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+6K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+6K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—