510(k) Report

Devices descending from K080401

840 later devices reach Shell Cage, Wave Cage, Loop Cage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130274Biolign Acif Systems, Biolign Stacc Acif System, Biolign Tlif SystemElite Surgical Supplies (Pty), Ltd.20139—
+1K121569Matisse Anterior Cervical Interbody Fusion Cage SystemAccel Spine20123—
+1K120840Lexus Cervical Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201214—
+1K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+1K110650Zyston Arc Interbody SpacerBiomet Spine (Aka Ebi, LLC)2011177—
+1K100945Fuse Plif CafeAdvanced Medical Technologies AG2011463—
+1K082801Phantom Plus Cage SystemUs Spine2008643—
+2K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+2K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+2K211413BEE PLIF CageNGMedical GmbH20211—
+2K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+2K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+2K172788MONET™ Anterior Cervical Interbody Fusion Cage SystemCtl Medical Corporation20181—
+2K172212MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™Ctl Medical Corporation20181—
+2K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+2K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+2K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+2K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+2K153517AnyPlus® Cervical PEEK Cage SystemGS Medical Co., Ltd.201612—
+2K153629ArcadiusXP C Spinal SystemAesculap Implant Systems, Inc.20167—
+2K153783SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIFSpinevision S.A.201613—
+2K150481Cascadia Interbody SystemK2m, Inc.20154593
+2K143360LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20159—
+2K140280ForticoreNanovis, LLC20149—
+2K140303Alamo TAlliance Partners, LLC20140—
+2K132582Exactech Acapella One Cervical Spacer SystemExactech, Inc.2014471
+2K132991C-Box Peek Cervical IbfInnovasis, Inc.20149—
+2K122957Tezo Titanium Cage FamilyUlrich GmbH & Co. KG20130—
+2K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…Bm Korea Co., Ltd.20133—
+2K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC)2012171—
+2K1217414-Web Cervical STS (Spinal Truss System)4-Web, Inc.201235—
+2K122085Stingray Cervical CageOmni Surgical, LP Dba Spine36020120—
+2K121892Phantom Plus Ceramic Cage SystemAmedica Corp.20127—
+2K103655Octane-C Interbody Fusion Device SystemExactech, Inc.2011481
+2K101363VU Cpod Intervertebral Bodu Fusion DeviceMusculoskeletal Clinical Regulatory Advisers201078—
+2K093093Small Plateau Spacer SystemLife Spine2010393—
+2K100889Endoskeleton TCTitan Spine, LLC2010455—
+3K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+3K261279DeltaNEC Interbody SystemNexus Spine20260—
+3K261067BEE PLIF CageNGMedical GmbH20260—
+3K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+3K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+3K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+3K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+3K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+3K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+3K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+3K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+3K223251Hexanium PLIFSpinevision, S.A.S.20220—
+3K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+3K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+3K200592GS Medical AnyPlus PEEK Cage SystemGS Medical Co., Ltd.20206—
+3K1920444CIS Marlin PEEK ACIF CageSolco Biomedical Co., Ltd.20190—
+3K191796Neo Cage SystemNeo Medical SA20190—
+3K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+3K183092Kuros TLIF CageKuros Biosciences B.V20190—
+3K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+3K181048Neo Cage System TMNeo Medical SA20191—
+3K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+3K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+3K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+3K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188—
+3K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+3K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+3K180437Hexanium® TLIFSpinevision, S.A.S.20182—
+3K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+3K172941CASCADIA Interbody SystemK2m201852—
+3K171312FortiCore®Nanovis, LLC20183—
+3K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+3K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+3K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+3K172419Velofix™ TLIF CageU&I Corporation20172—
+3K163595IMPIX 3D Print CagesMedicrea International SA2017282
+3K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies20176—
+3K171489Acapella Cervical Spacer SystemChoicespine, LP201739—
+3K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+3K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+3K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+3K170055CAPRI Corpectomy Cage SystemK2m201711—
+3K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+3K163364MOJAVE Expandable Interbody SystemK2m201725—
+3K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc.20166—
+3K162264Cascadia Interbody SystemK2m, Inc.2016169—
+3K161405Valeo II Interbody Fusion Device SystemAmedica Corp.20164—
+3K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemGenesys Spine201619—
+3K153621Juliet® TiSpineart2016751
+3K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+3K160154ALTA Anterior Cervical Interbody SpacerAstura Medical201663—
+3K160125Cascadia Interbody SystemK2m2016315—
+3K160547Cascadia Interbody SystemK2m2016157—
+3K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+3K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+3K151677LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20158—
+3K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+3K142347Amedica Valeo II Interbody Fusion DeviceAmedica Corp.20145—
+3K141953Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLTitan Spine, LLC20142652
+3K142589Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS…Titan Spine, LLC2014106—
+3K1421124WEB Spinal Implant Products4Web, Inc.201433—
+3K121649Construx Mini Peek TI Spacer SystemOrthofix2012289—
+3K112862Mecta-CMedacta International201114—