510(k) Report

Devices descending from K043479

1,214 later devices reach MC+ Partial VBR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+4K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+4K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+4K162587Roccia® AcifSilony Medical GmbH20171—
+4K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+4K162531Sterispine CCSafe Orthopaedics20160—
+4K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+4K161642CAVUX™ Cervical CageProvidence Medical Technology, Inc.20160—
+4K161379ELSA SpacersGlobus Medical, Inc.2016155—
+4K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+4K162264Cascadia Interbody SystemK2m, Inc.2016169—
+4K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201683—
+4K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+4K153621Juliet® TiSpineart2016751
+4K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+4K153786Prow Fusion-VNlt Spine, Ltd.20166—
+4K152622Alta ACDF SystemBiomet Spine20160—
+4K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+4K161280Cervical Stand Alone SystemOrthofix, Inc.201614—
+4K160125Cascadia Interbody SystemK2m2016315—
+4K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+4K160547Cascadia Interbody SystemK2m2016157—
+4K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+4K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+4K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+4K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+4K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110—
+4K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+4K151496Latitude-C Cervical Interbody Spacer SystemDegen Medical201513—
+4K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC20152—
+4K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+4K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+4K151727Everest Spinal SystemK2m, Inc.201511—
+4K150619CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc.2015107—
+4K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+4K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+4K151756Sterispine LC CageSafe Orthopaedics20150—
+4K151677LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20158—
+4K150321EVOS Lumbar Interbody SystemCutting Edge Spine, LLC201592—
+4K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+4K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+4K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+4K150521Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201512—
+4K142487Chesapeake Stabilization SystemK2m, Inc.201571
+4K142744Mecta-C TiPEEKMedacta International201512—
+4K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+4K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+4K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+4K142360Everest Spinal SystemK2m, Inc.201522—
+4K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+4K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+4K142277Juliet POSpineart2014119—
+4K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+4K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+4K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+4K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+4K141147Range Spinal SystemK2m, Inc.20141—
+4K133200Stalif C (R)Centinel Spine, Inc.201410—
+4K140474Juliet OLSpineart2014120—
+4K134038Camber Spine Diagon Oblique CageCamber Spine201428—
+4K133893Sterispine LC CageSafe Orthopaedics20141—
+4K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+4K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+4K133192Mectalif TipeekMedacta International201416—
+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—
+4K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+4K131951Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.201312—
+4K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc.2013709—
+4K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2012723—
+4K121982Sovereign Spinal SystemMedtronic Sofamor Danek2012155—
+5K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+5K261049Scala® TLSpineart SA20260—
+5K261408SABER-XA SystemElevation Spine20260—
+5K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+5K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+5K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K261279DeltaNEC Interbody SystemNexus Spine20260—
+5K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+5K260660SABER-C SystemElevation Spine20261—
+5K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+5K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+5K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+5K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+5K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+5K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+5K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+5K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+5K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+5K250560BEE HANGMedical GmbH20250—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+5K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+5K250540SABER-C SystemElevation Spine20252—
+5K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+5K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—