510(k) Report

Devices descending from K031914

1,530 later devices reach Spinal Concepts, Inc. Cadence and Fortitude through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201828—
+7K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+7K181337Sypher Spacer SystemBiogennix, LLC20180—
+7K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar SystemLife Spine, Inc.20182—
+7K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+7K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+7K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+7K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+7K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+7K180673Normandy VBR SystemZavation Medical Products, LLC20187—
+7K180695FBC 921 (Alif)Fbc Device Aps20180—
+7K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+7K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+7K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+7K181203Juliet TiSpineart20181—
+7K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+7K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+7K172480icotec Interbody Cage SystemIcotec AG20185—
+7K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+7K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+7K180437Hexanium® TLIFSpinevision, S.A.S.20182—
+7K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+7K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+7K180431Cortina [MAX] Lumbar Cage SystemNeurostructures, Inc.20181—
+7K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC20181052
+7K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+7K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+7K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+7K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+7K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+7K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+7K172009Cascadia Interbody SystemK2m, Inc.2017433
+7K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+7K172419Velofix™ TLIF CageU&I Corporation20172—
+7K172032Modulift Vertebral Body Replacement (VBR) SystemAesculap Implants Systems, Inc.201746—
+7K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+7K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+7K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+7K171489Acapella Cervical Spacer SystemChoicespine, LP201739—
+7K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+7K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+7K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+7K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—
+7K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+7K171704CAPRI Corpectomy Cage SystemK2m201710—
+7K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+7K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+7K170919The TiBow Expandable Spacer SystemLife Spine, Inc.20171—
+7K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+7K171630LumFuse-TPPrecifit Medical, Ltd.20171—
+7K171749Velofix (tm) Interbody Fusion SystemU&I Corporation20175—
+7K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+7K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+7K163506Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar…Vertera, Inc.2017224—
+7K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+7K162133VerteFIT Corpectomy Cage SystemLdr Spine USA, Inc.20170—
+7K162206Zavation IBFZavation, LLC201724—
+7K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+7K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc.20166—
+7K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+7K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+7K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+7K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+7K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+7K160074Rampart D Lumbar Interbody Fusion DeviceSpineology, Inc.20165—
+7K161379ELSA SpacersGlobus Medical, Inc.2016155—
+7K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+7K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+7K161405Valeo II Interbody Fusion Device SystemAmedica Corp.20164—
+7K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—
+7K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemGenesys Spine201619—
+7K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+7K153786Prow Fusion-VNlt Spine, Ltd.20166—
+7K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+7K160154ALTA Anterior Cervical Interbody SpacerAstura Medical201663—
+7K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+7K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+7K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+7K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+7K151406Cogent Lateral Interbody SystemCogent Spine, LLC201611—
+7K160291Optimus ALIF SystemAmendia, Inc.20160—
+7K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+7K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+7K152355Twin Peaks Lumbar Interbody Fusion SystemSpineway20151—
+7K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+7K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC20152—
+7K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+7K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+7K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+7K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+7K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+7K151756Sterispine LC CageSafe Orthopaedics20150—
+7K151374NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable…Nu Vasive, Incorporated2015235—
+7K151677LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20158—
+7K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+7K142392Zavation Posterior LEIFZavation, LLC20150—
+7K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+7K150206InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20152—
+7K143616AccuLIF TL and PL CageStryker Corporation20154694
+7K143228Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc.20150—