510(k) Report

Devices descending from K003155

2,091 later devices reach Vertebral Body Replacement through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+6K162206Zavation IBFZavation, LLC201724—
+6K170347CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA201791—
+6K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+6K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+6K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.20162—
+6K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+6K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company20160—
+6K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+6K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+6K160663Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)Evolution Spine, LLC20160—
+6K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201645—
+6K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+6K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+6K161842Overwatch Spine SystemAmendia, Inc.201661
+6K162494CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201627—
+6K161379ELSA SpacersGlobus Medical, Inc.2016155—
+6K161129Pillar SA PTCOrthofix, Inc.201619—
+6K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+6K161627PASS LP Spinal SystemMedicrea International SA20167—
+6K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemGenesys Spine201619—
+6K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+6K153621Juliet® TiSpineart2016751
+6K153786Prow Fusion-VNlt Spine, Ltd.20166—
+6K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+6K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+6K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+6K153436LATERAL Spine Truss System4Web, Inc.20165—
+6K160154ALTA Anterior Cervical Interbody SpacerAstura Medical201663—
+6K160324Cervical Interbody Fusion SystemEvolution Spine, LLC20162—
+6K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+6K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+6K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+6K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+6K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+6K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+6K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+6K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+6K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+6K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110—
+6K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+6K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated2016159—
+6K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+6K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+6K152532AERO -C Cervical Cage SystemStryker Spine2015145—
+6K152355Twin Peaks Lumbar Interbody Fusion SystemSpineway20151—
+6K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+6K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+6K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC20152—
+6K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+6K151819Integrity Spine Lumbar Interbody Fusion SystemIntegrity Spine Lumbar Interbody Fusion System20154—
+6K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+6K152457CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2015145—
+6K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+6K143450Ackermann Intervertebral Body Fusion DeviceAckermann Instrumente GmbH20150—
+6K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+6K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+6K150812Genesys Spine Apache Cervical Interbody Fusion SystemGenesys Spine201512—
+6K151756Sterispine LC CageSafe Orthopaedics20150—
+6K151374NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable…Nu Vasive, Incorporated2015235—
+6K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+6K150321EVOS Lumbar Interbody SystemCutting Edge Spine, LLC201592—
+6K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+6K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+6K143572Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance…Osteomed Implantes, Ltda20150—
+6K151215Mercury Spinal SystemSpinal Elements, Inc.20158—
+6K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+6K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+6K141798Sypher Spacer SystemBiogennix, LLC20151—
+6K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+6K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+6K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+6K142360Everest Spinal SystemK2m, Inc.201522—
+6K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+6K142328nvcNvision Biomedical Technologies, LLC20144—
+6K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+6K143141CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201416—
+6K142594nva, nvp, nvtNvision Biomedical Technologies, LLC20144—
+6K141333Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.20140—
+6K142499Reline SystemNu Vasive, Incorporated201478—
+6K133827A-Link ZOsteo Vasive, LLC2014262
+6K142847CD HORIZON Spinal SystemMedtronic Sofamor Danck USA, Inc.2014286—
+6K142026Spinefrontier Arena-C HA Peek Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.2014190—
+6K142277Juliet POSpineart2014119—
+6K140577Innesis Peek TL CageBk Meditech, Co., Ltd.20142—
+6K141337Arena-CSpinefrontier, Inc.20141—
+6K141372Mercury Spinal SystemSpinal Elements, Inc.20149—
+6K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+6K141005Z-Link CervicalZavation, LLC20144—
+6K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+6K141605CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014210—
+6K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+6K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+6K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+6K141147Range Spinal SystemK2m, Inc.20141—
+6K132852Peek Cage for the Vertebral SpineNeoortho Produtos Ortopedicos S/A20140—
+6K140529Everest Spinal SystemK2m, LLC201431—
+6K123607Octane Elevate Spinal Implant SystemExactech, Inc.20141—
+6K140010Fortress Pedicle Screw SystemSpineology, Inc.201411—
+6K140474Juliet OLSpineart2014120—