510(k) Report

Devices descending from K023835

1,227 later devices reach Devex Mesh System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+3K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+3K162693VertebraLINK Fusion PlatformFacetlink Dba Linkspine20170—
+3K163474CAVUX CervicalCage-L SA SystemProvidence Medical Technology, Inc.20170—
+3K163180Hubble IIOrbbo Surgical, LLC20160—
+3K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc.20166—
+3K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+3K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+3K160646XYcor® Expandable Spinal Spacer SystemAlphatec Spine, Inc.201641—
+3K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+3K160631Keos Lumbar IBFDKeos20161—
+3K160125Cascadia Interbody SystemK2m2016315—
+3K160547Cascadia Interbody SystemK2m2016157—
+3K153400ProLift Expandable SystemLife Spine, Inc.201672—
+3K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+3K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110—
+3K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+3K152532AERO -C Cervical Cage SystemStryker Spine2015145—
+3K152515TOMCAT Cervical Spinal SystemChoicespine, LP2015108—
+3K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+3K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+3K150481Cascadia Interbody SystemK2m, Inc.20154593
+3K142744Mecta-C TiPEEKMedacta International201512—
+3K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+3K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+3K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+3K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc.2015280—
+3K141333Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.20140—
+3K140319Coroent TI-C SystemNuvasive, Inc.2014590—
+3K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+3K133717Longbow Spacer SystemLife Spine20149—
+3K133813Flxfit Intervertebral Body Fusion DeviceExpanding Orthopedics, Inc.2014137—
+3K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+3K132738Cogent Med-LifCogent Spine, LLC201413—
+3K132999Cervical Stand Alone SystemOrthofix, Inc.2014281—
+3K132596Proposed OptimusCustom Spine, Inc.201451
+3K133614Aleutian Ibf SystemK2m, Inc.2014527—
+3K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+3K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC20145—
+3K133967Interbody Cage SystemAurora Spine2014227—
+3K133192Mectalif TipeekMedacta International201416—
+3K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424—
+3K131724Pioneer Maxfuse Vertebral Body Replacement DevicePioneer Surgical Technology, Inc.201373—
+3K133126K7 Lumbar SpacersK7, LLC20131—
+3K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013119—
+3K130699Aleutian Spinal SystemK2m, Inc.2013570—
+3K124034Mectalif AnteriorMedacta International201311—
+3K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+3K123388K7C SpacerK7, LLC20130—
+3K121649Construx Mini Peek TI Spacer SystemOrthofix2012289—
+3K121151Pro-Link Cervical Spacer SystemLife Spine, Inc.2012116—
+3K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC)2012171—
+3K122896Cougar LS 15 Lateral Cage SystemMedos International SARL2012205—
+3K122366Tryptik CC Anterior Intersomatic Cervical CageSpineart20125—
+3K120819Stalif CCentinel Spine, Inc.2012206—
+3K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+3K111726Pathway AvidCustom Spine, Inc.201295—
+3K112664Zavation Ibf SystemsZavation, LLC201137—
+3K112359Prow FusionNlt Spine, Ltd.2011601—
+3K102315Staxx XDL SystemSpine Wave, Inc.20113—
+3K111774Pathway Model 07XXXXCustom Spine201115—
+3K103743Concorde Curve SystemJohnson & Johnson20110—
+3K091425Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd.201031—
+3K093242Patriot Transcontinental Llif SpacerGlobus Medical, Inc.2009921—
+3K072326Ostapek VBR SystemCo-Ligne AG20081—
+4K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+4K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+4K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+4K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+4K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+4K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+4K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+4K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+4K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+4K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+4K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+4K242195Gemini Cervical Fusion Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+4K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+4K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+4K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+4K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+4K240699SCARLET® AC-TiSpineart SA20240—
+4K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+4K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+4K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+4K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+4K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+4K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+4K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+4K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+4K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+4K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+4K231359RODIN™ Expandable Lumbar Cage SystemCtl Medical Corporation20230—
+4K230329F3D Interbody SystemCorelink, LLC20230—
+4K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+4K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+4K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+4K223430ProLift Micro Expandable Spacer SystemLife Spine, Inc.20236—
+4K230583Tryptik TiSpineart SA20231—
+4K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—