510(k) Report

Devices descending from K072253

1,250 later devices reach Synfix-LR Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K1920444CIS Marlin PEEK ACIF CageSolco Biomedical Co., Ltd.20190—
+4K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+4K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+4K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+4K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+4K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+4K191134IB3D AlifMedicrea International SA20191—
+4K1803473d CageFims Co., Ltd.20190—
+4K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+4K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+4K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+4K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+4K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+4K183407Triton CageMedyssey USA, Inc.20190—
+4K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+4K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+4K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+4K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+4K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+4K191408Nexxt Matrixx SystemNexxt Spine, 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—
+4K183064TxTi IBF SystemInnovasis, Inc.2019481
+4K182139AXTi Titanium Stand-Alone ALIF SystemInnovasis, Inc.201972—
+4K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+4K191263Idys ALIF TiVacClariance, Sas20190—
+4K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+4K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+4K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+4K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+4K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+4K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+4K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+4K183049Reliance Lumbar IBF SystemReliance Medical Systems, LLC20197—
+4K182477Cervical SpacerAdditive Implants, LLC201915—
+4K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+4K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+4K181970MectaLIF Posterior ExtensionMedacta International S.A.20182—
+4K182470Plateau Spacer SystemLife Spine20180—
+4K181590Neurostructures Cavetto® [MAX] Cervical Cage SystemNeurostructures, Inc.20180—
+4K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+4K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+4K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+4K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+4K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+4K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188—
+4K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+4K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+4K180687Reliance Lumber IBF SystemReliance Medical Systems20188—
+4K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+4K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+4K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+4K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+4K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+4K173128Alamo® CAlliance Partners, LLC20182—
+4K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC20181052
+4K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+4K171312FortiCore®Nanovis, LLC20183—
+4K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+4K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+4K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+4K172009Cascadia Interbody SystemK2m, Inc.2017433
+4K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+4K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies20176—
+4K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+4K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+4K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+4K172065Scarlet AC-TSpineart20172—
+4K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+4K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+4K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+4K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+4K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+4K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+4K170550Coveris Cervical Cage SystemCamber Spine Technologies20171—
+4K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+4K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+4K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+4K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+4K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+4K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+4K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+4K162986SPIRA Open Matrix ALIFCamber Spine Technologies201711—
+4K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+4K170055CAPRI Corpectomy Cage SystemK2m201711—
+4K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+4K163364MOJAVE Expandable Interbody SystemK2m201725—
+4K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+4K163543Biomet Fusion SystemZimmer Biomet Spine, Inc.2017124—
+4K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+4K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+4K163180Hubble IIOrbbo Surgical, LLC20160—
+4K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education20160—
+4K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+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—
+4K160074Rampart D Lumbar Interbody Fusion DeviceSpineology, Inc.20165—
+4K161379ELSA SpacersGlobus Medical, Inc.2016155—
+4K162264Cascadia Interbody SystemK2m, Inc.2016169—