510(k) Report

Devices descending from K041722

1,150 later devices reach Modification to VBR Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+3K163180Hubble IIOrbbo Surgical, LLC20160—
+3K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc.20166—
+3K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+3K161405Valeo II Interbody Fusion Device SystemAmedica Corp.20164—
+3K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+3K160463Reliance Lumbar IBF SystemReliance Medical Systems, LLC201611—
+3K160125Cascadia Interbody SystemK2m2016315—
+3K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+3K160547Cascadia Interbody SystemK2m2016157—
+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—
+3K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+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—
+3K140563Lateral VBR SystemNu Vasive, Incorporated20140—
+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—
+3K133207Staxx (R) SystemSpine Wave, Inc.20131—
+3K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013119—
+3K130478Sustain and Sustain Radiolucent SpacersGlobus Medical, Inc.2013256—
+3K130699Aleutian Spinal SystemK2m, Inc.2013570—
+3K124034Mectalif AnteriorMedacta International201311—
+3K123913Latis SpacerGlobus Medical, Inc.201388—
+3K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+3K123388K7C SpacerK7, LLC20130—
+3K122097Patriot SpacersGlobus Medical, Inc.2012261—
+3K121649Construx Mini Peek TI Spacer SystemOrthofix2012289—
+3K121151Pro-Link Cervical Spacer SystemLife Spine, Inc.2012116—
+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
+3K113540Reliance Lumbar Ibf SystemReliance Medical Systems, LLC201212—
+3K112664Zavation Ibf SystemsZavation, LLC201137—
+3K103382Intercontinental Plate-SpacerGlobus Medical, Inc.2011554—
+3K103729Infill Intervertebral Body Fusion DevicePinnacle Spine Group, LLC201122—
+3K103743Concorde Curve SystemJohnson & Johnson20110—
+3K102293Caliber SpacerGlobus Medical, Inc.2011869—
+3K102313Patriot Transcontinental M SpacersGlobus Medical, Inc.2010361—
+3K101051Avs a-Lat Peek Spacers, Models 48750XXX, 48751XXX, 48752XXX, 48753XXXStryker Spine2010641—
+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—
+4K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+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—
+4K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+4K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+4K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+4K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+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—
+4K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+4K230583Tryptik TiSpineart SA20231—
+4K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+4K223043The Integrity Spine Core SystemIntegrity Spine20230—
+4K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+4K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+4K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+4K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—