510(k) Report

Devices descending from K011037

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+5K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc.20166—
+5K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education20160—
+5K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+5K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+5K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+5K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+5K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+5K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+5K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+5K162264Cascadia Interbody SystemK2m, Inc.2016169—
+5K153665Prow Fusion-LNlt Spine, Ltd.20160—
+5K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201683—
+5K161888JULIET® LL Lateral Lumbar CageSpineart2016145—
+5K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+5K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+5K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+5K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+5K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+5K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+5K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+5K161280Cervical Stand Alone SystemOrthofix, Inc.201614—
+5K160154ALTA Anterior Cervical Interbody SpacerAstura Medical201663—
+5K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+5K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+5K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+5K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+5K151406Cogent Lateral Interbody SystemCogent Spine, LLC201611—
+5K160291Optimus ALIF SystemAmendia, Inc.20160—
+5K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+5K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—
+5K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+5K151496Latitude-C Cervical Interbody Spacer SystemDegen Medical201513—
+5K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+5K152355Twin Peaks Lumbar Interbody Fusion SystemSpineway20151—
+5K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+5K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+5K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+5K151785Px HA PEEK IBF SystemInnovasis, Inc.201557—
+5K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+5K143479Bluefin Interbody SystemTides Medical20152—
+5K150619CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc.2015107—
+5K150847Foundation Interbody DevicesCorelink, LLC201529—
+5K143572Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance…Osteomed Implantes, Ltda20150—
+5K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015368—
+5K140348Interbody CageEisertech, LLC2015235—
+5K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+5K143297Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody…Zimmer Spine, Inc.201519—
+5K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+5K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+5K141333Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.20140—
+5K141942Midline II TICentinel Spine, Inc.2014459—
+5K142150Ais Modulift VBR SystemAesculap Implant System, Inc.201447—
+5K141953Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLTitan Spine, LLC20142652
+5K142589Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS…Titan Spine, LLC2014106—
+5K142193Cogent Med-Lif XLCogent Spine, LLC201412—
+5K142095Renovis S134 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014254—
+5K141791Biomet Fusion SystemBiomet Spine2014128—
+5K133717Longbow Spacer SystemLife Spine20149—
+5K140280ForticoreNanovis, LLC20149—
+5K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+5K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+5K133947Irix-a Lumbar Integrated Fusion SystemX-Spine Systems, Inc.20142—
+5K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+5K140709Skyhawk Interbody Fusion SystemOrthofix, Inc.20147—
+5K133802Ais Modulift VBR SystemAesculap Implant System, Inc.201448—
+5K133340Spineworks Anterior Lumbar DeviceSpineworks, LLC201413—
+5K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC20145—
+5K132991C-Box Peek Cervical IbfInnovasis, Inc.20149—
+5K133967Interbody Cage SystemAurora Spine2014227—
+5K123758Tasmin RSignus Medizintechnik GmbH20141—
+5K133286Midline (TM)Centinel Spine, Inc.2014460—
+5K131540Interfuse L Intervertebral Body Fusion DeviceVertebral Technologies, Inc.20136—
+5K130461Stalif XCentinel Spine, Inc.201313—
+5K131547Lanx Fusion SystemLanx, Inc.20131631
+5K131671MectalifMedacta International201322—
+5K131372Mobis IISignus Medizintechnik GmbH2013462—
+5K122957Tezo Titanium Cage FamilyUlrich GmbH & Co. KG20130—
+5K130506Imse P-TlifInstitute of Musculoskeletal Science & Education20130—
+5K123997TRANS1LATERAL Interbody Fusion SystemTrans1, Inc.2013173—
+5K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+5K122872Intervertebral Body Fusion DeviceDio Medical Co., Ltd.201316—
+5K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…Bm Korea Co., Ltd.20133—
+5K121254Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies201340—
+5K121693A-Wedge Anterior Interbody System (a-Wedge Ais)Sapphire Medical Group, Inc.201221—
+5K122956Fuselox Lumbar Interbody Fusion DeviceCaptiva Spine20122—
+5K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC)2012171—
+5K1217414-Web Cervical STS (Spinal Truss System)4-Web, Inc.201235—
+5K122366Tryptik CC Anterior Intersomatic Cervical CageSpineart20125—
+5K122021Sterispine LC CageSafe Orthopaedics20122—
+5K122317Tetris IISignus Medizintechnik GmbH20122—
+5K121982Sovereign Spinal SystemMedtronic Sofamor Danek2012155—
+5K121116Plateau Spacer SystemLife Spine201213—
+5K112696Twin Peaks Lumbar CageQualgenix, LLC20120—
+5K120656Everest Spinal SystemK2m, Inc.201243—
+5K120576Zavation Ibf SystemZavation, LLC201232—
+5K113540Reliance Lumbar Ibf SystemReliance Medical Systems, LLC201212—
+5K110063Sovereign Spinal SystemMedtronic Sofamor Danek, Inc.2011718—
+5K111626Endoskeleton (R) TasTitan Spine, LLC2011273—
+5K110650Zyston Arc Interbody SpacerBiomet Spine (Aka Ebi, LLC)2011177—