510(k) Report

Devices descending from K071922

1,221 later devices reach Interplate Interbody Fusion Device, Models C, CGC, L and LGC through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K181397DualXInnovasive, Inc.201815—
+4K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+4K181337Sypher Spacer SystemBiogennix, LLC20180—
+4K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+4K181380LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201810—
+4K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+4K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+4K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+4K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+4K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+4K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+4K181246Zavation IBF SystemZavation Medical Products, LLC201822—
+4K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+4K181203Juliet TiSpineart20181—
+4K180674EVOL® ha-C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20183—
+4K180502S128 Anterior Lumbar Interbody Fusion (ALIF) SystemRenovis Surgical Technologies, Inc.201811—
+4K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+4K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+4K172480icotec Interbody Cage SystemIcotec AG20185—
+4K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+4K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+4K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+4K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+4K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+4K172947HALF DOME Posterior Lumbar Interbody SystemAstura Medical201822—
+4K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+4K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC20181052
+4K172941CASCADIA Interbody SystemK2m201852—
+4K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+4K172816TiGer Shark™ SystemChoicespine, LP201859—
+4K173283Reliance Lumbar IBF SystemReliance Medical Systems, LLC20189—
+4K173508Everest Spinal SystemK2m20189—
+4K173702Juliet Ti LLSpineart20182—
+4K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+4K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+4K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+4K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+4K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+4K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+4K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+4K172419Velofix™ TLIF CageU&I Corporation20172—
+4K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+4K172083Idys™ ALIF SystemClariance, Sas20177—
+4K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+4K173080IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)Huvexel Co., Ltd.20172—
+4K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+4K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+4K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+4K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—
+4K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+4K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+4K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+4K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+4K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+4K170919The TiBow Expandable Spacer SystemLife Spine, Inc.20171—
+4K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+4K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+4K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+4K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+4K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+4K161710Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion CervicalSpinal Analytics & Geometrical Impant Co, LLC201741—
+4K163506Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar…Vertera, Inc.2017224—
+4K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+4K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+4K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+4K162496Foundation 3D InterbodyCorelink, LLC201782—
+4K170055CAPRI Corpectomy Cage SystemK2m201711—
+4K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+4K163364MOJAVE Expandable Interbody SystemK2m201725—
+4K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+4K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+4K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+4K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+4K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+4K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+4K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+4K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+4K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+4K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+4K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+4K160074Rampart D Lumbar Interbody Fusion DeviceSpineology, Inc.20165—
+4K160076XCage™ Interbody Fusion SystemOuroboros Medical, Inc.2016141
+4K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+4K162264Cascadia Interbody SystemK2m, Inc.2016169—
+4K161888JULIET® LL Lateral Lumbar CageSpineart2016145—
+4K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+4K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+4K160646XYcor® Expandable Spinal Spacer SystemAlphatec Spine, Inc.201641—
+4K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+4K160631Keos Lumbar IBFDKeos20161—
+4K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+4K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP2016171—
+4K153615NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC201650—
+4K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+4K160125Cascadia Interbody SystemK2m2016315—
+4K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+4K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+4K160547Cascadia Interbody SystemK2m2016157—
+4K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+4K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies201632—