510(k) Report

Devices descending from K011037

1,374 later devices reach Vertebral Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K152622Alta ACDF SystemBiomet Spine20160—
+4K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP2016171—
+4K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+4K160125Cascadia Interbody SystemK2m2016315—
+4K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+4K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+4K152200SurgTech Interbody SystemSurgtech, Inc.20160—
+4K160547Cascadia Interbody SystemK2m2016157—
+4K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+4K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+4K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+4K151939COALITION SpacersGlobus Medical, Inc.2016152—
+4K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+4K150455RT2 Trabeculite Titanium Cervical Cage SystemRhausler, Inc.20150—
+4K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC20152—
+4K143450Ackermann Intervertebral Body Fusion DeviceAckermann Instrumente GmbH20150—
+4K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+4K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+4K150481Cascadia Interbody SystemK2m, Inc.20154593
+4K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+4K150500Px PEEK IBF SystemInnovasis, Inc.201558—
+4K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+4K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+4K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+4K150521Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201512—
+4K150152The Octane Straight Intervertebral Fusion Device, Ti CoatedExactech, Inc.201510—
+4K142744Mecta-C TiPEEKMedacta International201512—
+4K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+4K142996StaXx (R) XD SystemSpine Wave, Inc.20150—
+4K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+4K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc.2015280—
+4K141135Juliet LLSpineart2014146—
+4K133827A-Link ZOsteo Vasive, LLC2014262
+4K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+4K142277Juliet POSpineart2014119—
+4K141005Z-Link CervicalZavation, LLC20144—
+4K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+4K132852Peek Cage for the Vertebral SpineNeoortho Produtos Ortopedicos S/A20140—
+4K140474Juliet OLSpineart2014120—
+4K132738Cogent Med-LifCogent Spine, LLC201413—
+4K132999Cervical Stand Alone SystemOrthofix, Inc.2014281—
+4K132596Proposed OptimusCustom Spine, Inc.201451
+4K133614Aleutian Ibf SystemK2m, Inc.2014527—
+4K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+4K133455Crossfuse II Coronal Taper, Crossfuse II HyperlordoticPioneer Surgical Technology, Inc.20145961
+4K140106S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014265—
+4K133529Camber Spine Coveris Cervical CageCamber Spine201410—
+4K133623C-PLUSPioneer Surgical Technology, Inc.2014598—
+4K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+4K132421Aesculap Peek XP Spinal Implant SystemAesculap Implant Systems, Inc.201414—
+4K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424—
+4K133126K7 Lumbar SpacersK7, LLC20131—
+4K131350Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.2013214
+4K131178Idys Lif CagesClariance201311—
+4K131981Cezanne II Interbody Fusion SystemAccel Spine201354
+4K130573Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC2013251—
+4K131077Life Spine Plateau Spacer SystemLife Spine201310—
+4K122588Vusion CS PlusOrtho Development Corp.2013206—
+4K130699Aleutian Spinal SystemK2m, Inc.2013570—
+4K122639Synthes Syncage Evolution SpacerSynthes (USA) Products, LLC2013143—
+4K123045Brigade Standalone SystemNuvasive, Inc.2013696—
+4K123909Aesculap Cespace XPAesculap Implant System, Inc.20137—
+4K123767Lanx Fusion System- SALanx, Inc.20133244
+4K123993Solus Anterior Lumbar Interbody Fusion (Alif) SystemAlphatec Spine, Inc.20130—
+4K123388K7C SpacerK7, LLC20130—
+4K121649Construx Mini Peek TI Spacer SystemOrthofix2012289—
+4K123207Primalif TM Llif Unitary Peek Lateral Lumbar Interbody Fusion SystemOsteomed LP201216—
+4K120869Anchor-L Lumbar CageStryker Spine2012638—
+4K122444Cervical CageEisertech, LLC201222—
+4K120203TM-400 DeviceZimmer Trabecular Metal Technology, Inc.201220—
+4K120396Reliance Cervical Ibf SystemReliance Medical Systems, LLC201225—
+4K120557Solitarie Peek Anterior Spinal System-to BE Called Colitaire 35Biomet Spine & Bone Healing Technologies20121—
+4K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd.201220—
+4K112561Nuvasive Coroent NO-Profile SystemNuvasive, Inc.201212—
+4K113478Plif CageEisertech, LLC2012269—
+4K111792Mobis, Moval, Semial, Tetrismodel Peek and Titanium, Kimba Model Standard and MiniSignus Medizintechnik GmbH2012470—
+4K120024Mectalif TransforaminalMedacta International S.A.201223—
+4K113138Aleutian SystemK2m, Inc.2012549—
+4K112664Zavation Ibf SystemsZavation, LLC201137—
+4K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+4K112014Zyston Straight Spacer SystemBiomet Spine2011174—
+4K112496Pioneer Crossfuse II Ibf/VBR SystemPioneer Surgical Technology, Inc.2011604—
+4K111166A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC201123—
+4K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc.2011460—
+4K110915Cervical CageEisertech, LLC201123—
+4K110864Biospine VBR SystemAesculap Implant Systems, LLC201149—
+4K103111Forza Spacer SystemOrthofix, Inc.20113431
+4K103814Pezo Interbody Cages SystemUlrich GmbH & Co. KG20114—
+4K103169AleuttianK2m, Inc.2011572—
+4K100210TRANS1 Lateral Intervertebral Fusion Device, TTrans1 Incorporated2010175—
+4K100865Ava Navigator Peek Spacers, Model 48392XXX, 48393XXXStryker Spine2010637—
+4K100889Endoskeleton TCTitan Spine, LLC2010455—
+4K100544Impix Lumbar Interbody DeviceMedicrea Technologies201001
+4K101302Aleutian Ibf SystemK2m, Inc.2010595—
+4K101720Juliet OLSpineart2010259—
+4K093629Solitaire and Solitaire Peek Anterior Spinal SystemBiomet Spine20101431
+4K092540C-PS Peek Optima Cervical Interbody Spacer, L-PS Peek Optima Lumbar Interbody SpacerRsb Spine, LLC201045—
+4K093675Interfuse Invertebral Body Fusion Device Model 9076Vertebral Technologies, Inc.20090—
+4K091813Intrepid Spinal SystemMedtronic Sofamor Danek2009719—
+4K091988Modification to: Interfuse Intervertebral Body Fusion Device , Model 9076Vertebral Technologies, Inc.2009101—