510(k) Report

Devices descending from K001340

2,423 later devices reach Stackable Cage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K152011Lucent Intervertebral Body Fusion DeviceSpinal Elements, Inc.2016106—
+5K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+5K153436LATERAL Spine Truss System4Web, Inc.20165—
+5K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP2016171—
+5K160154ALTA Anterior Cervical Interbody SpacerAstura Medical201663—
+5K160324Cervical Interbody Fusion SystemEvolution Spine, LLC20162—
+5K153720ENZA Zero-Profile Anterior Interbody FusionCamber Spine Technologies20164—
+5K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+5K153413PASS LP Spinal SystemMedicrea International SA20160—
+5K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+5K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+5K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+5K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies201632—
+5K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+5K152539SpineView X-Pac Expandable Lumbar Cage SystemSpine View, Inc.20166—
+5K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+5K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+5K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+5K153695Biomet Spine Fusion SystemBiomet Spine, LLC201632
+5K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+5K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated2016159—
+5K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+5K151496Latitude-C Cervical Interbody Spacer SystemDegen Medical201513—
+5K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+5K152304Tritanium PL CageStryker20154481
+5K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC20152—
+5K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+5K151819Integrity Spine Lumbar Interbody Fusion SystemIntegrity Spine Lumbar Interbody Fusion System20154—
+5K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+5K152457CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2015145—
+5K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+5K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+5K143450Ackermann Intervertebral Body Fusion DeviceAckermann Instrumente GmbH20150—
+5K150619CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc.2015107—
+5K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+5K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+5K150812Genesys Spine Apache Cervical Interbody Fusion SystemGenesys Spine201512—
+5K151756Sterispine LC CageSafe Orthopaedics20150—
+5K151140LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201529—
+5K151374NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable…Nu Vasive, Incorporated2015235—
+5K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+5K150321EVOS Lumbar Interbody SystemCutting Edge Spine, LLC201592—
+5K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+5K142645Avenue T TLIF CageLdr Spine USA, Inc.2015191—
+5K143572Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance…Osteomed Implantes, Ltda20150—
+5K151215Mercury Spinal SystemSpinal Elements, Inc.20158—
+5K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+5K140348Interbody CageEisertech, LLC2015235—
+5K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+5K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+5K150206InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20152—
+5K143616AccuLIF TL and PL CageStryker Corporation20154694
+5K143228Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc.20150—
+5K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+5K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+5K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+5K142360Everest Spinal SystemK2m, Inc.201522—
+5K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+5K142328nvcNvision Biomedical Technologies, LLC20144—
+5K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+5K143141CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201416—
+5K142594nva, nvp, nvtNvision Biomedical Technologies, LLC20144—
+5K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+5K142499Reline SystemNu Vasive, Incorporated201478—
+5K142847CD HORIZON Spinal SystemMedtronic Sofamor Danck USA, Inc.2014286—
+5K142026Spinefrontier Arena-C HA Peek Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.2014190—
+5K142095Renovis S134 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014254—
+5K142277Juliet POSpineart2014119—
+5K141791Biomet Fusion SystemBiomet Spine2014128—
+5K140577Innesis Peek TL CageBk Meditech, Co., Ltd.20142—
+5K142450DIVERGENCE Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.20146—
+5K141337Arena-CSpinefrontier, Inc.20141—
+5K141372Mercury Spinal SystemSpinal Elements, Inc.20149—
+5K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+5K141005Z-Link CervicalZavation, LLC20144—
+5K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+5K141605CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014210—
+5K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+5K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+5K141147Range Spinal SystemK2m, Inc.20141—
+5K132852Peek Cage for the Vertebral SpineNeoortho Produtos Ortopedicos S/A20140—
+5K140529Everest Spinal SystemK2m, LLC201431—
+5K133200Stalif C (R)Centinel Spine, Inc.201410—
+5K123607Octane Elevate Spinal Implant SystemExactech, Inc.20141—
+5K140010Fortress Pedicle Screw SystemSpineology, Inc.201411—
+5K140474Juliet OLSpineart2014120—
+5K133815Intess Cervical Cage SystemKalitec Direct, LLC20144—
+5K133340Spineworks Anterior Lumbar DeviceSpineworks, LLC201413—
+5K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+5K140003Coroent Small Interbody SystemNuvasive, Inc.2014453—
+5K133529Camber Spine Coveris Cervical CageCamber Spine201410—
+5K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+5K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+5K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+5K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+5K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+5K133583Opticage Interbody Fusion Device, Model Series 9070Interventional Spine, Inc.20140—
+5K132421Aesculap Peek XP Spinal Implant SystemAesculap Implant Systems, Inc.201414—
+5K131880Spinefrontier a-Cift Solofuse Cervical Intervertebral Fusion Device SystemSpinefrontier, Inc.201427—
+5K132559Monument SpacersGlobus Medical, Inc.2013166—