510(k) Report

Devices descending from K010530

1,764 later devices reach Geo Structure through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K133126K7 Lumbar SpacersK7, LLC20131—
+4K132718Integrity Spine Core SystemIntegrity Spine20131—
+4K130254Prow FusionNlt Spine, Ltd.20138—
+4K130820Expandable Lumbar Interbody SystemNu Vasive, Incorporated2013593—
+4K122639Synthes Syncage Evolution SpacerSynthes (USA) Products, LLC2013143—
+4K123913Latis SpacerGlobus Medical, Inc.201388—
+4K123045Brigade Standalone SystemNuvasive, Inc.2013696—
+4K123767Lanx Fusion System- SALanx, Inc.20133244
+4K123993Solus Anterior Lumbar Interbody Fusion (Alif) SystemAlphatec Spine, Inc.20130—
+4K123206Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical2013454—
+4K123388K7C SpacerK7, LLC20130—
+4K120869Anchor-L Lumbar CageStryker Spine2012638—
+4K121103LDR Spine Usa Spine Tune, TL Spinal System, LDR Spine Usa Easyspine, Posterior Spinal…Ldr Spine USA, Inc.201216—
+4K120203TM-400 DeviceZimmer Trabecular Metal Technology, Inc.201220—
+4K120345Honour Spacer SystemNexxt Spine, LLC2012212—
+4K120275Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC2012173—
+4K120396Reliance Cervical Ibf SystemReliance Medical Systems, LLC201225—
+4K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+4K120557Solitarie Peek Anterior Spinal System-to BE Called Colitaire 35Biomet Spine & Bone Healing Technologies20121—
+4K112561Nuvasive Coroent NO-Profile SystemNuvasive, Inc.201212—
+4K111792Mobis, Moval, Semial, Tetrismodel Peek and Titanium, Kimba Model Standard and MiniSignus Medizintechnik GmbH2012470—
+4K120024Mectalif TransforaminalMedacta International S.A.201223—
+4K112862Mecta-CMedacta International201114—
+4K112459Synthes Zero-PSynthes Spine Co.Lp2011277—
+4K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+4K112068Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp2011331
+4K112496Pioneer Crossfuse II Ibf/VBR SystemPioneer Surgical Technology, Inc.2011604—
+4K110659Medical Concepts Interbody Fusion SystemMedical Concepts, Inc.20111—
+4K111166A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC201123—
+4K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc.2011460—
+4K110650Zyston Arc Interbody SpacerBiomet Spine (Aka Ebi, LLC)2011177—
+4K103111Forza Spacer SystemOrthofix, Inc.20113431
+4K103814Pezo Interbody Cages SystemUlrich GmbH & Co. KG20114—
+4K100698STCCCardinal Spine, LLC2011346—
+4K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+4K093762Synthes Zero-PSynthes Spine20103061
+4K101363VU Cpod Intervertebral Bodu Fusion DeviceMusculoskeletal Clinical Regulatory Advisers201078—
+4K103034Genesys Spine Interbody Fusion SystemGenesys Spine20101371
+4K100042Difusion Technologies Xiphos Interbody Fusion SystemDifusion Technologies2010864—
+4K100210TRANS1 Lateral Intervertebral Fusion Device, TTrans1 Incorporated2010175—
+4K100865Ava Navigator Peek Spacers, Model 48392XXX, 48393XXXStryker Spine2010637—
+4K100544Impix Lumbar Interbody DeviceMedicrea Technologies201001
+4K101720Juliet OLSpineart2010259—
+4K092521ZUMA-CSeaspine, Inc.2010168—
+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—
+4K092904Pathway Ivb/VBRCustom Spine, Inc.2009296—
+4K091813Intrepid Spinal SystemMedtronic Sofamor Danek2009719—
+4K091988Modification to: Interfuse Intervertebral Body Fusion Device , Model 9076Vertebral Technologies, Inc.2009101—
+4K091088LDR Spine Cervical Interbody Fusion SystemLdr Spine USA2009901—
+4K090816Stryker Spine Avs PL Peek SpacersStryker Corp.2009756—
+4K090166Avs Anterior Large Peek SpacersStryker Corp.2009683—
+4K083815Lanx Fusion SystemLanx, Inc.2009451—
+4K090064Eminent Spine Interbody Fusion SystemEminent Spine20097011
+4K083661Avs TL Peek SpacersStryker Corp.2009757—
+4K083475Lucent MagnumSpinal Elements, Inc.2009834—
+4K083857LDR Spine Roi-C ImplantLdr Spine USA2009902—
+4K082406Expandable Peek-Optima ImplantEbi, L.P.2009527—
+4K081849Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc.20087531
+4K082014Stryker Spine Avs PL Peek SpacersStryker Corp.2008837—
+4K081383Reliance VBS SystemReliance Medical Systems, LLC20080—
+4K080971Spinesmith Cimplicity Spinal SystemSpine Smith Partners L.P.2008406—
+4K072326Ostapek VBR SystemCo-Ligne AG20081—
+4K073109Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd.2008907—
+4K080728LDR Spine Roi-C ImplantLdr Spine USA2008903—
+4K080569LDR Spine Roi-T ImplantLdr Spine USA20080—
+4K080572LDR Spine Roi-a ImplantLdr Spine USA2008113—
+4K080758Avs PL Peek Spacers, Models 48351 and 48353Stryker Corp.20081,091—
+4K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.20071,405—
+4K063637Reliance VBS SystemReliance Medical Systems, LLC20071—
+4K072132LDR Spine Roi-T SystemLdr Spine USA20071—
+4K063464Atlas Spine Vertebral Body ReplacementAtlas Spine, Inc.20072—
+4K062151Box Peek VBR SystemInnovasis, Inc.2006175—
+4K061752Spinal Usa VBR SystemSpinal USA20060—
+4K061151Pioneer Vertebral Spacer (Vertebral Spacer)Pioneer Surgical Technology2006801—
+4K052210Nuvasive Coroent Extensure SystemNuvasive, Inc.2005263—
+4K051205Stryker Spine Avs Asl Peek SpacerStryker Spine2005829—
+4K051454Aleutian Spacer SystemK2m, LLC2005666—
+4K051246Construx Mini Peek VBR SystemBlackstone Medical, Inc.2005834—
+4K050624Stryker Spine Avs PL Peek SpacerStryker Spine2005892—
+4K042571Stryker Spine Avs TL Peek SpacerStryker Spine2005894—
+5K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+5K261049Scala® TLSpineart SA20260—
+5K261408SABER-XA SystemElevation Spine20260—
+5K261430TruLift Expandable SystemLife Spine, Inc.20260—
+5K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+5K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+5K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+5K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+5K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+5K242303MOD-COrthomod, LLC20260—
+5K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+5K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—