510(k) Report

Devices descending from K020048

1,559 later devices reach Modification to Geo Structure through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+8K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+8K192117Small VBR™Ulrich GmbH & Co. KG20196—
+8K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+8K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+8K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+8K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+8K183243Velofix TLIF CageU&I Corporation20190—
+8K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+8K191263Idys ALIF TiVacClariance, Sas20190—
+8K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+8K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+8K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+8K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+8K182721Choice Spine Navigation SystemChoicespine, LP20192—
+8K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+8K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+8K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201828—
+8K181337Sypher Spacer SystemBiogennix, LLC20180—
+8K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar SystemLife Spine, Inc.20182—
+8K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+8K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+8K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+8K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+8K180673Normandy VBR SystemZavation Medical Products, LLC20187—
+8K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+8K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+8K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+8K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+8K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+8K172480icotec Interbody Cage SystemIcotec AG20185—
+8K180437Hexanium® TLIFSpinevision, S.A.S.20182—
+8K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+8K180431Cortina [MAX] Lumbar Cage SystemNeurostructures, Inc.20181—
+8K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+8K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+8K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+8K172032Modulift Vertebral Body Replacement (VBR) SystemAesculap Implants Systems, Inc.201746—
+8K171489Acapella Cervical Spacer SystemChoicespine, LP201739—
+8K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+8K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—
+8K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+8K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+8K171630LumFuse-TPPrecifit Medical, Ltd.20171—
+8K171749Velofix (tm) Interbody Fusion SystemU&I Corporation20175—
+8K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+8K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+8K162133VerteFIT Corpectomy Cage SystemLdr Spine USA, Inc.20170—
+8K162496Foundation 3D InterbodyCorelink, LLC201782—
+8K162206Zavation IBFZavation, LLC201724—
+8K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc.20166—
+8K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+8K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+8K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+8K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+8K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+8K160074Rampart D Lumbar Interbody Fusion DeviceSpineology, Inc.20165—
+8K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+8K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+8K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+8K161405Valeo II Interbody Fusion Device SystemAmedica Corp.20164—
+8K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—
+8K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemGenesys Spine201619—
+8K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+8K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+8K160154ALTA Anterior Cervical Interbody SpacerAstura Medical201663—
+8K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+8K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+8K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+8K152355Twin Peaks Lumbar Interbody Fusion SystemSpineway20151—
+8K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+8K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+8K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+8K143479Bluefin Interbody SystemTides Medical20152—
+8K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+8K151756Sterispine LC CageSafe Orthopaedics20150—
+8K151677LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20158—
+8K142392Zavation Posterior LEIFZavation, LLC20150—
+8K150206InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20152—
+8K143616AccuLIF TL and PL CageStryker Corporation20154694
+8K143228Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc.20150—
+8K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+8K142271Zavation Z-Link LumbarZavation, LLC20149—
+8K141333Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.20140—
+8K141896Coroent SystemNu Vasive, Incorporated2014480—
+8K142347Amedica Valeo II Interbody Fusion DeviceAmedica Corp.20145—
+8K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+8K141942Midline II TICentinel Spine, Inc.2014459—
+8K142150Ais Modulift VBR SystemAesculap Implant System, Inc.201447—
+8K142095Renovis S134 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014254—
+8K133577Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2014256—
+8K141005Z-Link CervicalZavation, LLC20144—
+8K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+8K140529Everest Spinal SystemK2m, LLC201431—
+8K133802Ais Modulift VBR SystemAesculap Implant System, Inc.201448—
+8K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+8K134038Camber Spine Diagon Oblique CageCamber Spine201428—
+8K133967Interbody Cage SystemAurora Spine2014227—
+8K131276Lateral SynfixSynthes (USA) Products, LLC2014146—
+8K132757Everest Spinal SystemK2m, Inc.201341—