510(k) Report

Devices descending from K024364

1,683 later devices reach Synthes Vertebral Spacer TI (Curved and Narrow) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+4K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+4K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+4K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+4K203444BEE HA CageNGMedical GmbH20211—
+4K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+4K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+4K201145X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20204—
+4K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+4K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+4K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+4K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+4K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+4K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+4K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+4K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+4K192117Small VBR™Ulrich GmbH & Co. KG20196—
+4K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+4K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+4K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+4K183407Triton CageMedyssey USA, Inc.20190—
+4K190885Elevation Spine Saber-C SystemElevation Spine201925—
+4K191423Normandy VBR SystemZavation Medical Products, LLC20193—
+4K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+4K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+4K182139AXTi Titanium Stand-Alone ALIF SystemInnovasis, Inc.201972—
+4K190147COLOSSEUM MeshGlobus Medical, Inc.20190—
+4K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+4K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+4K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+4K183071VLIFT-s Vertebral Body Replacement SystemStryker Spine20194—
+4K181818Scarlet AL-TSpineart201864—
+4K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+4K180673Normandy VBR SystemZavation Medical Products, LLC20187—
+4K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+4K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+4K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+4K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+4K172032Modulift Vertebral Body Replacement (VBR) SystemAesculap Implants Systems, Inc.201746—
+4K162315FORTIFY Corpectomy SpacersGlobus Medical, Inc.201755—
+4K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+4K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+4K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+4K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+4K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+4K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+4K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+4K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+4K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+4K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+4K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+4K161129Pillar SA PTCOrthofix, Inc.201619—
+4K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+4K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+4K153720ENZA Zero-Profile Anterior Interbody FusionCamber Spine Technologies20164—
+4K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+4K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+4K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+4K150521Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201512—
+4K140348Interbody CageEisertech, LLC2015235—
+4K143490VERTA Corpectomy CageCamber Spine20151—
+4K133827A-Link ZOsteo Vasive, LLC2014262
+4K141942Midline II TICentinel Spine, Inc.2014459—
+4K142016CAPRIK2m, Inc.201412—
+4K142150Ais Modulift VBR SystemAesculap Implant System, Inc.201447—
+4K140563Lateral VBR SystemNu Vasive, Incorporated20140—
+4K132907Plif Lite and Tlif LiteSintea Plustek20140—
+4K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC20145—
+4K133455Crossfuse II Coronal Taper, Crossfuse II HyperlordoticPioneer Surgical Technology, Inc.20145961
+4K133623C-PLUSPioneer Surgical Technology, Inc.2014598—
+4K131292Deroyal Spine Spacer SystemDeroyal Industries, Inc.20140—
+4K123758Tasmin RSignus Medizintechnik GmbH20141—
+4K133286Midline (TM)Centinel Spine, Inc.2014460—
+4K132718Integrity Spine Core SystemIntegrity Spine20131—
+4K124034Mectalif AnteriorMedacta International201311—
+4K123206Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical2013454—
+4K123388K7C SpacerK7, LLC20130—
+4K121103LDR Spine Usa Spine Tune, TL Spinal System, LDR Spine Usa Easyspine, Posterior Spinal…Ldr Spine USA, Inc.201216—
+4K121107Fortify Integrated Corpectomy Spacers, (Fortify I and Fortify I-R)Globus Medical, Inc.2012214—
+4K121211VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2012129—
+4K120570Choice Spine Vertebral Body Replacement (VBR) Device SystemChoicespine, LP2012322—
+4K111294Santorini Spinal SystemK2m, Inc.201218—
+4K112429Giza (R) Vertebral Body ReplacementEden Spine, LLC201221
+4K112496Pioneer Crossfuse II Ibf/VBR SystemPioneer Surgical Technology, Inc.2011604—
+4K110659Medical Concepts Interbody Fusion SystemMedical Concepts, Inc.20111—
+4K102315Staxx XDL SystemSpine Wave, Inc.20113—
+4K111469Staxxsd SystemSpine Wave, Inc.20110—
+4K110650Zyston Arc Interbody SpacerBiomet Spine (Aka Ebi, LLC)2011177—
+4K110864Biospine VBR SystemAesculap Implant Systems, LLC201149—
+4K103034Genesys Spine Interbody Fusion SystemGenesys Spine20101371
+4K102067Endoskeleton toTitan Spine, LLC2010337—
+4K100042Difusion Technologies Xiphos Interbody Fusion SystemDifusion Technologies2010864—
+4K092774Atlas Intervertebral Body CageSpinal Edge, LLC20100—
+4K092540C-PS Peek Optima Cervical Interbody Spacer, L-PS Peek Optima Lumbar Interbody SpacerRsb Spine, LLC201045—
+4K092904Pathway Ivb/VBRCustom Spine, Inc.2009296—
+4K090315Staxx XD SystemSpine Wave, Inc.20096—
+4K091088LDR Spine Cervical Interbody Fusion SystemLdr Spine USA2009901—
+4K083815Lanx Fusion SystemLanx, Inc.2009451—
+4K090064Eminent Spine Interbody Fusion SystemEminent Spine20097011
+4K083857LDR Spine Roi-C ImplantLdr Spine USA2009902—