510(k) Report

Devices descending from K003043

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+6K172484A-CIFT SoloFuseSpinefrontier, Inc.201871
+6K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+6K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+6K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+6K180431Cortina [MAX] Lumbar Cage SystemNeurostructures, Inc.20181—
+6K173324ALTA Anterior Cervical Interbody SpacerAstura Medical201827—
+6K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC20181052
+6K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+6K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+6K172816TiGer Shark™ SystemChoicespine, LP201859—
+6K173283Reliance Lumbar IBF SystemReliance Medical Systems, LLC20189—
+6K172212MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™Ctl Medical Corporation20181—
+6K173702Juliet Ti LLSpineart20182—
+6K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+6K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+6K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+6K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+6K172419Velofix™ TLIF CageU&I Corporation20172—
+6K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+6K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+6K172083Idys™ ALIF SystemClariance, Sas20177—
+6K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+6K173080IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)Huvexel Co., Ltd.20172—
+6K171489Acapella Cervical Spacer SystemChoicespine, LP201739—
+6K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+6K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+6K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+6K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+6K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+6K161710Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion CervicalSpinal Analytics & Geometrical Impant Co, LLC201741—
+6K163506Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar…Vertera, Inc.2017224—
+6K170569SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201782—
+6K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+6K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+6K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+6K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+6K162496Foundation 3D InterbodyCorelink, LLC201782—
+6K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+6K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+6K162236Ax Stand-Alone ALIF SystemInnovasis, Inc.201774—
+6K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+6K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC2017143—
+6K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+6K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+6K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+6K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+6K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+6K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+6K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+6K160076XCage™ Interbody Fusion SystemOuroboros Medical, Inc.2016141
+6K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+6K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+6K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+6K152622Alta ACDF SystemBiomet Spine20160—
+6K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+6K153436LATERAL Spine Truss System4Web, Inc.20165—
+6K153615NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC201650—
+6K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+6K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+6K151939COALITION SpacersGlobus Medical, Inc.2016152—
+6K152620Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc.20162—
+6K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+6K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+6K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+6K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+6K151934ROI-C Titanium-Coated Implant SystemLdr Spine USA20159—
+6K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC20152—
+6K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+6K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+6K143479Bluefin Interbody SystemTides Medical20152—
+6K150765LDR Spine ROI-C Cervical Cage SystemLdr Spine USA201559—
+6K151756Sterispine LC CageSafe Orthopaedics20150—
+6K151374NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable…Nu Vasive, Incorporated2015235—
+6K151198A-CIFT SoloFuseSpinefrontier, Inc.20158—
+6K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+6K150362NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2015441—
+6K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+6K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015368—
+6K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+6K150152The Octane Straight Intervertebral Fusion Device, Ti CoatedExactech, Inc.201510—
+6K150913Incite Anchored Cervical Interbody DeviceIncite Innovation20150—
+6K142392Zavation Posterior LEIFZavation, LLC20150—
+6K143360LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20159—
+6K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+6K142634Biomet Spine Fusion SystemBiomet Spine, LLC20155—
+6K142498MAGNIFY and MAGNIFY-S SpacersGlobus Medical, Inc.2015175—
+6K142996StaXx (R) XD SystemSpine Wave, Inc.20150—
+6K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+6K142271Zavation Z-Link LumbarZavation, LLC20149—
+6K141537IN:C2 Spinal Fixation SystmeSpine Smith Holdings, LLC20140—
+6K140716Opticage Expandable Interbody Fusion DeviceInterventional Spine, Inc.20140—
+6K142050Nuvasive Coroent Small Contoured Interbody SystemNu Vasive, Incorporated2014449—
+6K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+6K1421124WEB Spinal Implant Products4Web, Inc.201433—
+6K141405Mobis II ST Spinal ImplantSignus Medizintechnik GmbH2014461—
+6K140280ForticoreNanovis, LLC20149—
+6K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+6K140921Coroent Small Interbody SystemNu Vasive, Incorporated2014444—
+6K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—