510(k) Report

Devices descending from K042930

1,440 later devices reach Spacevision Cage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K182477Cervical SpacerAdditive Implants, LLC201915—
+4K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+4K180228II-Type Intervertebral SpacerPaonan Biotech Co., Ltd.20191—
+4K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+4K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+4K182322Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+4K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+4K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+4K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+4K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+4K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+4K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+4K180502S128 Anterior Lumbar Interbody Fusion (ALIF) SystemRenovis Surgical Technologies, Inc.201811—
+4K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+4K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+4K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+4K172941CASCADIA Interbody SystemK2m201852—
+4K172816TiGer Shark™ SystemChoicespine, LP201859—
+4K171312FortiCore®Nanovis, LLC20183—
+4K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+4K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+4K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+4K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+4K163595IMPIX 3D Print CagesMedicrea International SA2017282
+4K172083Idys™ ALIF SystemClariance, Sas20177—
+4K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+4K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+4K172065Scarlet AC-TSpineart20172—
+4K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+4K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+4K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+4K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+4K171140Matrixx SystemNexxt Spine, LLC2017145—
+4K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+4K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+4K170676HD Lumbar Interbody SystemHd Lifesciences, LLC2017122—
+4K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+4K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+4K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+4K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+4K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+4K170055CAPRI Corpectomy Cage SystemK2m201711—
+4K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+4K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+4K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+4K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+4K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+4K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+4K162264Cascadia Interbody SystemK2m, Inc.2016169—
+4K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+4K153621Juliet® TiSpineart2016751
+4K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+4K151900VariLift-L Interbody Fusion DeviceWenzel Spine, Inc.20158—
+4K150321EVOS Lumbar Interbody SystemCutting Edge Spine, LLC201592—
+4K150500Px PEEK IBF SystemInnovasis, Inc.201558—
+4K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+4K150521Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201512—
+4K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+4K141798Sypher Spacer SystemBiogennix, LLC20151—
+4K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+4K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+4K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+4K133053Milestone Spinal SystemWeigao Orthopaedic Device Co., Ltd.20142—
+4K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC20145—
+4K133455Crossfuse II Coronal Taper, Crossfuse II HyperlordoticPioneer Surgical Technology, Inc.20145961
+4K140106S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014265—
+4K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+4K132991C-Box Peek Cervical IbfInnovasis, Inc.20149—
+4K133623C-PLUSPioneer Surgical Technology, Inc.2014598—
+4K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Medtronic Sofamor Danek USA, Inc.20146—
+4K133650Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2013344—
+4K132897Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.2013279—
+4K130274Biolign Acif Systems, Biolign Stacc Acif System, Biolign Tlif SystemElite Surgical Supplies (Pty), Ltd.20139—
+4K131981Cezanne II Interbody Fusion SystemAccel Spine201354
+4K131296Varilift-L Interbody Fusion DeviceWenzel Spine, Inc.20130—
+4K131082Interform Interbody Cage SystemNext Orthosurgical2013595—
+4K131425Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale InserterMedtronic Navigation, Inc.201324610
+4K131671MectalifMedacta International201322—
+4K122588Vusion CS PlusOrtho Development Corp.2013206—
+4K130506Imse P-TlifInstitute of Musculoskeletal Science & Education20130—
+4K123978Capstone L Spinal SystemMedtronic Sofamor Danek USA201313—
+4K121254Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies201340—
+4K122956Fuselox Lumbar Interbody Fusion DeviceCaptiva Spine20122—
+4K122366Tryptik CC Anterior Intersomatic Cervical CageSpineart20125—
+4K122021Sterispine LC CageSafe Orthopaedics20122—
+4K122047Alamo PAlliance Partners, LLC20120—
+4K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2012723—
+4K121569Matisse Anterior Cervical Interbody Fusion Cage SystemAccel Spine20123—
+4K120840Lexus Cervical Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201214—
+4K120396Reliance Cervical Ibf SystemReliance Medical Systems, LLC201225—
+4K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc.2012761—
+4K120576Zavation Ibf SystemZavation, LLC201232—
+4K113478Plif CageEisertech, LLC2012269—
+4K113528Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011361—
+4K112862Mecta-CMedacta International201114—
+4K110562Telamon Peek Spinal SystemMedtronic Sofamor Danek USA2011306—
+4K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+4K112496Pioneer Crossfuse II Ibf/VBR SystemPioneer Surgical Technology, Inc.2011604—
+4K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011808—
+4K111569Plateau Spacer SystemLife Spine2011181—