510(k) Report

Devices descending from K003043

1,819 later devices reach Surgical Titanium Mesh System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+6K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+6K212562Idys-C ZP 3DTiClariance, SA20211—
+6K211689KEYSTONE PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20212—
+6K201793EDEN Peek CageJmt Co., Ltd.20210—
+6K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+6K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+6K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+6K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+6K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+6K211413BEE PLIF CageNGMedical GmbH20211—
+6K211501Advantage-C PEEK Cervical lnterbody Fusion DeviceLntelivation, LLC20211—
+6K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+6K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+6K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+6K211306LabyrinthZavation Medical Products, LLC20213—
+6K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+6K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+6K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+6K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+6K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+6K202032Idys LLIF 3DTiClariance, Sas20210—
+6K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+6K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+6K200429BEE CagesNGMedical GmbH202111—
+6K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+6K201287Impulse Interbody Fusion SystemDegen Medical20208—
+6K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+6K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+6K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+6K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+6K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+6K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+6K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+6K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+6K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+6K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+6K201769Cavetto [MAX] Cervical Cage SystemNeurostructures, Inc.20200—
+6K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+6K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+6K201087CORBEL SpacersGlobus Medical, Inc.202036—
+6K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+6K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+6K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+6K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+6K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+6K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+6K193258ProLift Expandable SystemLife Spine, Inc.20203—
+6K192993Scarlet AL-TSpineart20201—
+6K193645nva, nvp, and nvtNvision Biomedical Technologies, Inc.20203—
+6K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+6K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+6K1920444CIS Marlin PEEK ACIF CageSolco Biomedical Co., Ltd.20190—
+6K191796Neo Cage SystemNeo Medical SA20190—
+6K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+6K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+6K191134IB3D AlifMedicrea International SA20191—
+6K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC20193—
+6K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+6K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+6K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+6K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+6K183407Triton CageMedyssey USA, Inc.20190—
+6K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+6K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+6K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+6K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+6K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+6K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+6K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+6K183064TxTi IBF SystemInnovasis, Inc.2019481
+6K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+6K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+6K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+6K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+6K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+6K190380nvcNvision Biomedical Technologies, Inc.20193—
+6K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+6K190055Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20191—
+6K183259Idys™ TLIF TiVacClariance, Sas20191—
+6K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+6K183049Reliance Lumbar IBF SystemReliance Medical Systems, LLC20197—
+6K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+6K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+6K181048Neo Cage System TMNeo Medical SA20191—
+6K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+6K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+6K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+6K181590Neurostructures Cavetto® [MAX] Cervical Cage SystemNeurostructures, Inc.20180—
+6K181337Sypher Spacer SystemBiogennix, LLC20180—
+6K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+6K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+6K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+6K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+6K181246Zavation IBF SystemZavation Medical Products, LLC201822—
+6K181203Juliet TiSpineart20181—
+6K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+6K172788MONET™ Anterior Cervical Interbody Fusion Cage SystemCtl Medical Corporation20181—
+6K180674EVOL® ha-C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20183—
+6K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—