510(k) Report

Devices descending from K003155

2,091 later devices reach Vertebral Body Replacement through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K162496Foundation 3D InterbodyCorelink, LLC201782—
+7K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+7K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+7K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+7K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+7K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemSurgtech, Inc.20170—
+7K162693VertebraLINK Fusion PlatformFacetlink Dba Linkspine20170—
+7K162921Navigated Instrument SystemOrthofix, Inc.20175—
+7K163474CAVUX CervicalCage-L SA SystemProvidence Medical Technology, Inc.20170—
+7K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+7K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+7K162786PASS LP Spinal SystemMedicrea International SA20176—
+7K162531Sterispine CCSafe Orthopaedics20160—
+7K163180Hubble IIOrbbo Surgical, LLC20160—
+7K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+7K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc.20166—
+7K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education20160—
+7K160879CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsMedos International Sàrl2016106—
+7K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+7K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+7K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+7K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+7K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+7K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+7K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+7K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+7K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+7K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+7K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+7K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+7K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+7K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+7K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+7K161028K2M Growing Spine SystemK2m, Inc.20163—
+7K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+7K160631Keos Lumbar IBFDKeos20161—
+7K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+7K153615NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC201650—
+7K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+7K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+7K153404Zavation Spinal SystemZavation, LLC20161—
+7K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+7K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+7K152200SurgTech Interbody SystemSurgtech, Inc.20160—
+7K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+7K151939COALITION SpacersGlobus Medical, Inc.2016152—
+7K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+7K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+7K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—
+7K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+7K152515TOMCAT Cervical Spinal SystemChoicespine, LP2015108—
+7K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+7K151934ROI-C Titanium-Coated Implant SystemLdr Spine USA20159—
+7K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+7K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+7K151974Polaris Spinal SystemBiomet Spine201516—
+7K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+7K143479Bluefin Interbody SystemTides Medical20152—
+7K150765LDR Spine ROI-C Cervical Cage SystemLdr Spine USA201559—
+7K151727Everest Spinal SystemK2m, Inc.201511—
+7K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+7K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+7K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+7K150481Cascadia Interbody SystemK2m, Inc.20154593
+7K151140LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201529—
+7K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+7K151216Everest Spinal SystemK2m, Inc.201511—
+7K151128CAPSTONE Spinal System, CLYDESDALE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015255—
+7K151198A-CIFT SoloFuseSpinefrontier, Inc.20158—
+7K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+7K142645Avenue T TLIF CageLdr Spine USA, Inc.2015191—
+7K150362NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2015441—
+7K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+7K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+7K142744Mecta-C TiPEEKMedacta International201512—
+7K150913Incite Anchored Cervical Interbody DeviceIncite Innovation20150—
+7K142392Zavation Posterior LEIFZavation, LLC20150—
+7K140348Interbody CageEisertech, LLC2015235—
+7K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+7K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+7K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201588—
+7K143360LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20159—
+7K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+7K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+7K142531F1-Modular Pedicle Screw SystemDegen Medical20152—
+7K150390Nautilus Spinal SystemLife Spine, Inc.20150—
+7K143616AccuLIF TL and PL CageStryker Corporation20154694
+7K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+7K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+7K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+7K142030STGC-LordoticCardinal Spine, LLC201558—
+7K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+7K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc.2015280—
+7K142271Zavation Z-Link LumbarZavation, LLC20149—
+7K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+7K143403Threshold Pedicular Fixation SystemSpineology, Inc.20148—
+7K141135Juliet LLSpineart2014146—
+7K141537IN:C2 Spinal Fixation SystmeSpine Smith Holdings, LLC20140—
+7K141896Coroent SystemNu Vasive, Incorporated2014480—
+7K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—