510(k) Report

Devices descending from K010530

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K151819Integrity Spine Lumbar Interbody Fusion SystemIntegrity Spine Lumbar Interbody Fusion System20154—
+5K151785Px HA PEEK IBF SystemInnovasis, Inc.201557—
+5K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+5K143479Bluefin Interbody SystemTides Medical20152—
+5K150812Genesys Spine Apache Cervical Interbody Fusion SystemGenesys Spine201512—
+5K150847Foundation Interbody DevicesCorelink, LLC201529—
+5K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+5K151374NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable…Nu Vasive, Incorporated2015235—
+5K151654Prow FusionNlt Spine, Ltd.20151—
+5K143572Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance…Osteomed Implantes, Ltda20150—
+5K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+5K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015368—
+5K142744Mecta-C TiPEEKMedacta International201512—
+5K142634Biomet Spine Fusion SystemBiomet Spine, LLC20155—
+5K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+5K142328nvcNvision Biomedical Technologies, LLC20144—
+5K142594nva, nvp, nvtNvision Biomedical Technologies, LLC20144—
+5K141333Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.20140—
+5K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+5K142023Luna Interbody SystemBenvenue Medical, Inc.20145—
+5K141942Midline II TICentinel Spine, Inc.2014459—
+5K142026Spinefrontier Arena-C HA Peek Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.2014190—
+5K142095Renovis S134 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014254—
+5K141791Biomet Fusion SystemBiomet Spine2014128—
+5K141337Arena-CSpinefrontier, Inc.20141—
+5K140280ForticoreNanovis, LLC20149—
+5K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+5K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+5K141005Z-Link CervicalZavation, LLC20144—
+5K133947Irix-a Lumbar Integrated Fusion SystemX-Spine Systems, Inc.20142—
+5K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+5K140770MLX - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2014269—
+5K140162AP Expandable Xlif SystemNuvasive, Inc.2014236—
+5K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+5K140709Skyhawk Interbody Fusion SystemOrthofix, Inc.20147—
+5K133815Intess Cervical Cage SystemKalitec Direct, LLC20144—
+5K132999Cervical Stand Alone SystemOrthofix, Inc.2014281—
+5K133340Spineworks Anterior Lumbar DeviceSpineworks, LLC201413—
+5K140003Coroent Small Interbody SystemNuvasive, Inc.2014453—
+5K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+5K133529Camber Spine Coveris Cervical CageCamber Spine201410—
+5K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424—
+5K133286Midline (TM)Centinel Spine, Inc.2014460—
+5K131880Spinefrontier a-Cift Solofuse Cervical Intervertebral Fusion Device SystemSpinefrontier, Inc.201427—
+5K131724Pioneer Maxfuse Vertebral Body Replacement DevicePioneer Surgical Technology, Inc.201373—
+5K130913Genesys Spine Apache Lateral Lumbar Interbody Fusion SystemGenesys Spine201314—
+5K130317Genesys Spine Apache Ibfd Star Cervical SystemGenesys Spine20139—
+5K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+5K131981Cezanne II Interbody Fusion SystemAccel Spine201354
+5K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+5K131540Interfuse L Intervertebral Body Fusion DeviceVertebral Technologies, Inc.20136—
+5K130461Stalif XCentinel Spine, Inc.201313—
+5K131449Coalition SpacerGlobus Medical, Inc.2013235—
+5K131077Life Spine Plateau Spacer SystemLife Spine201310—
+5K131547Lanx Fusion SystemLanx, Inc.20131631
+5K121178Transcorp Acif SystemTranscorp, Inc.20130—
+5K131671MectalifMedacta International201322—
+5K131372Mobis IISignus Medizintechnik GmbH2013462—
+5K122957Tezo Titanium Cage FamilyUlrich GmbH & Co. KG20130—
+5K122588Vusion CS PlusOrtho Development Corp.2013206—
+5K123997TRANS1LATERAL Interbody Fusion SystemTrans1, Inc.2013173—
+5K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+5K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…Bm Korea Co., Ltd.20133—
+5K123969XiphosDifusion Technologies201314—
+5K123134Easyspine SystemLdr Spine USA, Inc.20131—
+5K120464Innesis Peek CageBk Meditech, Co., Ltd.20136—
+5K121693A-Wedge Anterior Interbody System (a-Wedge Ais)Sapphire Medical Group, Inc.201221—
+5K122630IN:C2 Spinal Fixation SystemSpine Smith Partners L.P.2012405—
+5K122008Incite Anchored Cervical Interbody (Aci) Fusion DeviceIncite Innovation, LLC201210—
+5K121581Box Peek VBR System,Innovasis, Inc.20121—
+5K120401Alamo TAlliance Partners, LLC20121—
+5K122444Cervical CageEisertech, LLC201222—
+5K122317Tetris IISignus Medizintechnik GmbH20122—
+5K121176STGCCardinal Spine, LLC201259—
+5K121320C7 Anterior Cervical Intervertebral Fusion CageMedyssey Co, Ltd.20122—
+5K121569Matisse Anterior Cervical Interbody Fusion Cage SystemAccel Spine20123—
+5K121982Sovereign Spinal SystemMedtronic Sofamor Danek2012155—
+5K121852Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp201230—
+5K120966Depuy Pulse Lumbar Cage SystemMedos International SARL201225—
+5K120840Lexus Cervical Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201214—
+5K121116Plateau Spacer SystemLife Spine201213—
+5K120517Depuy Pulse Cervical Cage SystemMedos International SARL20123—
+5K112696Twin Peaks Lumbar CageQualgenix, LLC20120—
+5K120656Everest Spinal SystemK2m, Inc.201243—
+5K120576Zavation Ibf SystemZavation, LLC201232—
+5K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd.201220—
+5K113540Reliance Lumbar Ibf SystemReliance Medical Systems, LLC201212—
+5K113518Arena-C Cervical Intervertebral Body Fusion SystemSpinefrontier, Inc.2012193—
+5K113138Aleutian SystemK2m, Inc.2012549—
+5K113559LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic ImplantsLdr Spine USA, Inc.2011383—
+5K112664Zavation Ibf SystemsZavation, LLC201137—
+5K111123Varilift Cervical Interbody Fusion SystemWenzel Spine2011196—
+5K111272Rhausler Plage Anterior Cervical Fusion SystemRhausler, Inc.20117—
+5K111512Bonebac T-Plif Intervertebral Body Fusion Device SystemThompson Mis, Inc.2011762—
+5K110063Sovereign Spinal SystemMedtronic Sofamor Danek, Inc.2011718—
+5K111484DiscoveryIntuitive Spine, LLC20111—
+5K111626Endoskeleton (R) TasTitan Spine, LLC2011273—
+5K102315Staxx XDL SystemSpine Wave, Inc.20113—
+5K111675VU C*Pod Intervertebral Body Fusion DeviceTheken Spine, LLC201162—
+5K110843Aleutian Spacer SystemK2m, Inc.2011589—