510(k) Report

Devices descending from P980048

1,422 later devices reach Bak/Cervical (Bak/C) Interbody Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+4K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+4K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+4K191796Neo Cage SystemNeo Medical SA20190—
+4K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+4K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+4K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+4K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+4K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+4K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+4K183407Triton CageMedyssey USA, Inc.20190—
+4K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+4K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+4K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+4K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+4K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+4K182139AXTi Titanium Stand-Alone ALIF SystemInnovasis, Inc.201972—
+4K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+4K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+4K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+4K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+4K183259Idys™ TLIF TiVacClariance, Sas20191—
+4K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+4K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+4K181048Neo Cage System TMNeo Medical SA20191—
+4K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+4K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+4K183071VLIFT-s Vertebral Body Replacement SystemStryker Spine20194—
+4K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+4K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+4K182470Plateau Spacer SystemLife Spine20180—
+4K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+4K182322Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+4K181818Scarlet AL-TSpineart201864—
+4K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+4K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+4K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar SystemLife Spine, Inc.20182—
+4K173893TrabisColigne AG20180—
+4K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+4K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+4K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+4K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+4K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188—
+4K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+4K173189Lumfuse TPPrecifit Medical, Ltd.20180—
+4K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+4K180437Hexanium® TLIFSpinevision, S.A.S.20182—
+4K172941CASCADIA Interbody SystemK2m201852—
+4K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+4K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+4K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+4K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+4K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+4K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+4K172009Cascadia Interbody SystemK2m, Inc.2017433
+4K172756Varian cageMedyssey USA, Inc.20171—
+4K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+4K173030Vertera Spine Cohere Cervical Interbody Fusion DeviceNu Vasive, Incorporated201722—
+4K162315FORTIFY Corpectomy SpacersGlobus Medical, Inc.201755—
+4K172083Idys™ ALIF SystemClariance, Sas20177—
+4K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+4K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+4K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+4K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+4K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+4K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+4K171140Matrixx SystemNexxt Spine, LLC2017145—
+4K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+4K170676HD Lumbar Interbody SystemHd Lifesciences, LLC2017122—
+4K170569SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201782—
+4K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+4K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+4K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+4K170055CAPRI Corpectomy Cage SystemK2m201711—
+4K163491NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2017289—
+4K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+4K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+4K163364MOJAVE Expandable Interbody SystemK2m201725—
+4K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+4K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+4K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+4K162587Roccia® AcifSilony Medical GmbH20171—
+4K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+4K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+4K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+4K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+4K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+4K161379ELSA SpacersGlobus Medical, Inc.2016155—
+4K162264Cascadia Interbody SystemK2m, Inc.2016169—
+4K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201683—
+4K161129Pillar SA PTCOrthofix, Inc.201619—
+4K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+4K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+4K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+4K161405Valeo II Interbody Fusion Device SystemAmedica Corp.20164—
+4K153621Juliet® TiSpineart2016751
+4K153786Prow Fusion-VNlt Spine, Ltd.20166—
+4K152622Alta ACDF SystemBiomet Spine20160—
+4K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+4K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—