510(k) Report

Devices descending from K990148

1,867 later devices reach Stackable Cage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+5K181963ostaPek Interbody Fusion CagesColigne AG20181—
+5K181590Neurostructures Cavetto® [MAX] Cervical Cage SystemNeurostructures, Inc.20180—
+5K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+5K182322Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+5K181337Sypher Spacer SystemBiogennix, LLC20180—
+5K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+5K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+5K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+5K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+5K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+5K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188—
+5K180673Normandy VBR SystemZavation Medical Products, LLC20187—
+5K181246Zavation IBF SystemZavation Medical Products, LLC201822—
+5K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+5K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+5K172788MONET™ Anterior Cervical Interbody Fusion Cage SystemCtl Medical Corporation20181—
+5K180674EVOL® ha-C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20183—
+5K180502S128 Anterior Lumbar Interbody Fusion (ALIF) SystemRenovis Surgical Technologies, Inc.201811—
+5K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+5K173189Lumfuse TPPrecifit Medical, Ltd.20180—
+5K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+5K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+5K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+5K172484A-CIFT SoloFuseSpinefrontier, Inc.201871
+5K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+5K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+5K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+5K173324ALTA Anterior Cervical Interbody SpacerAstura Medical201827—
+5K172941CASCADIA Interbody SystemK2m201852—
+5K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+5K172816TiGer Shark™ SystemChoicespine, LP201859—
+5K171312FortiCore®Nanovis, LLC20183—
+5K173283Reliance Lumbar IBF SystemReliance Medical Systems, LLC20189—
+5K172212MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™Ctl Medical Corporation20181—
+5K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+5K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+5K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+5K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+5K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+5K172756Varian cageMedyssey USA, Inc.20171—
+5K172419Velofix™ TLIF CageU&I Corporation20172—
+5K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+5K172083Idys™ ALIF SystemClariance, Sas20177—
+5K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies20176—
+5K173080IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)Huvexel Co., Ltd.20172—
+5K171914Cortina™ Lumbar Cage SystemNeurostructures, Inc.20172—
+5K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+5K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+5K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+5K172065Scarlet AC-TSpineart20172—
+5K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+5K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+5K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+5K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—
+5K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+5K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+5K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+5K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+5K163589SIGN IM NailSign Fracture Care International20170—
+5K170550Coveris Cervical Cage SystemCamber Spine Technologies20171—
+5K170676HD Lumbar Interbody SystemHd Lifesciences, LLC2017122—
+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
+5K161710Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion CervicalSpinal Analytics & Geometrical Impant Co, LLC201741—
+5K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+5K163506Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar…Vertera, Inc.2017224—
+5K170569SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201782—
+5K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+5K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+5K162496Foundation 3D InterbodyCorelink, LLC201782—
+5K170953Tomcat Cervical Spinal SystemChoicespine, LP2017103—
+5K162236Ax Stand-Alone ALIF SystemInnovasis, Inc.201774—
+5K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+5K163364MOJAVE Expandable Interbody SystemK2m201725—
+5K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+5K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+5K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+5K162531Sterispine CCSafe Orthopaedics20160—
+5K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education20160—
+5K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+5K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+5K160076XCage™ Interbody Fusion SystemOuroboros Medical, Inc.2016141
+5K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+5K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+5K162264Cascadia Interbody SystemK2m, Inc.2016169—
+5K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+5K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+5K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+5K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+5K153621Juliet® TiSpineart2016751
+5K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+5K161280Cervical Stand Alone SystemOrthofix, Inc.201614—
+5K153615NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC201650—
+5K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+5K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+5K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+5K152200SurgTech Interbody SystemSurgtech, Inc.20160—
+5K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+5K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies201632—