510(k) Report

Devices descending from K010530

1,764 later devices reach Geo Structure through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K173893TrabisColigne AG20180—
+5K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+5K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+5K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+5K173947Lumbar Interbody Fusion System (OLLIF)Advanced Research Medical, LLC201801
+5K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+5K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+5K181203Juliet TiSpineart20181—
+5K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+5K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+5K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+5K172480icotec Interbody Cage SystemIcotec AG20185—
+5K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+5K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+5K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+5K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+5K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+5K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+5K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+5K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+5K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+5K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+5K172816TiGer Shark™ SystemChoicespine, LP201859—
+5K171312FortiCore®Nanovis, LLC20183—
+5K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+5K173702Juliet Ti LLSpineart20182—
+5K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+5K172330Blustone Synergy Silica SystemBlustone Synergy20170—
+5K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+5K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+5K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+5K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+5K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+5K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+5K173148ACIFColigne AG20171—
+5K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+5K172083Idys™ ALIF SystemClariance, Sas20177—
+5K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+5K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+5K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+5K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+5K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+5K172065Scarlet AC-TSpineart20172—
+5K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+5K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+5K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+5K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+5K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+5K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+5K171704CAPRI Corpectomy Cage SystemK2m201710—
+5K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+5K171140Matrixx SystemNexxt Spine, LLC2017145—
+5K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+5K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+5K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+5K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+5K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+5K163494Summit Spine Channel Cervical Interbody Fusion SystemSummit Spine20171—
+5K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+5K163673Fortilink™-C with TETRAfuse™ 3D TechnologyRti Surgical, Inc.201711—
+5K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+5K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+5K162496Foundation 3D InterbodyCorelink, LLC201782—
+5K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+5K162206Zavation IBFZavation, LLC201724—
+5K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+5K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+5K163474CAVUX CervicalCage-L SA SystemProvidence Medical Technology, Inc.20170—
+5K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+5K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+5K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+5K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+5K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+5K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company20160—
+5K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+5K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+5K160663Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)Evolution Spine, LLC20160—
+5K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+5K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+5K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+5K161888JULIET® LL Lateral Lumbar CageSpineart2016145—
+5K161129Pillar SA PTCOrthofix, Inc.201619—
+5K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+5K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+5K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+5K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemGenesys Spine201619—
+5K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+5K153105MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2016234—
+5K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+5K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+5K160154ALTA Anterior Cervical Interbody SpacerAstura Medical201663—
+5K160324Cervical Interbody Fusion SystemEvolution Spine, LLC20162—
+5K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+5K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+5K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+5K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+5K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—
+5K152355Twin Peaks Lumbar Interbody Fusion SystemSpineway20151—
+5K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+5K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—