510(k) Report

Devices descending from K031635

1,201 later devices reach Depuy Acromed VBR System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+3K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+3K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+3K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+3K162693VertebraLINK Fusion PlatformFacetlink Dba Linkspine20170—
+3K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+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—
+3K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+3K161379ELSA SpacersGlobus Medical, Inc.2016155—
+3K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+3K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+3K153786Prow Fusion-VNlt Spine, Ltd.20166—
+3K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+3K160125Cascadia Interbody SystemK2m2016315—
+3K160547Cascadia Interbody SystemK2m2016157—
+3K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+3K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+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—
+3K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+3K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+3K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+3K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+3K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+3K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+3K150481Cascadia Interbody SystemK2m, Inc.20154593
+3K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+3K142005SpineFab Vertebral Body Replacement (VBR) SystemOxford Performance Materials201513—
+3K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+3K142744Mecta-C TiPEEKMedacta International201512—
+3K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+3K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+3K142030STGC-LordoticCardinal Spine, LLC201558—
+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—
+3K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+3K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+3K132999Cervical Stand Alone SystemOrthofix, Inc.2014281—
+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—
+3K133126K7 Lumbar SpacersK7, LLC20131—
+3K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013119—
+3K131636Polarus ConnectAcumed, LLC20130—
+3K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+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
+3K112664Zavation Ibf SystemsZavation, LLC201137—
+3K102315Staxx XDL SystemSpine Wave, Inc.20113—
+3K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.2011151
+3K103743Concorde Curve SystemJohnson & Johnson20110—
+3K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd.201115—
+3K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd.2011161
+3K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd.201029—
+3K093242Patriot Transcontinental Llif SpacerGlobus Medical, Inc.2009921—
+3K072326Ostapek VBR SystemCo-Ligne AG20081—
+4K261049Scala® TLSpineart SA20260—
+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—
+4K253158VyBrate™ VBR SystemVy Spine, LLC20260—
+4K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+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—
+4K250186GoLIF! Lumbar Interbody Fusion SystemGetset Surgical, SA20250—
+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—
+4K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+4K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+4K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+4K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+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—