510(k) Report

Devices descending from K093242

921 later devices reach Patriot Transcontinental Llif Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K250769Dakota LP SystemPrecision Spine, Inc.20250—
+3K250560BEE HANGMedical GmbH20250—
+3K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+3K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+3K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+3K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+3K241525ExcelsiusXR™Globus Medical, Inc.20250—
+3K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+3K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+3K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+3K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+3K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+3K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+3K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+3K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+3K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+3K240368E3D™-A Interbody SystemEvolution Spine20247—
+3K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+3K234150Lucent® XPSpinal Elements20240—
+3K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+3K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+3K232069Expandable Lumbar Fusion Cage (Type I,Type II)Shanghai Reach Medical Instrument Co, Ltd.20230—
+3K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+3K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+3K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+3K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+3K223143SAGICO Spinal SystemSagico VA USA, LLC20230—
+3K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+3K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+3K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+3K231359RODIN™ Expandable Lumbar Cage SystemCtl Medical Corporation20230—
+3K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+3K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+3K223430ProLift Micro Expandable Spacer SystemLife Spine, Inc.20236—
+3K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+3K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+3K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+3K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+3K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+3K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+3K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+3K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+3K220334MONET Anterior Cervical Plate SystemCtl Medical Corporation20220—
+3K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+3K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+3K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+3K222797X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20221—
+3K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+3K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+3K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+3K221687Pegasus-X Expandable PLIF SystemGS Medical Co., Ltd.20220—
+3K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+3K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+3K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+3K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+3K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+3K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+3K213441PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20222—
+3K212930LumiVy Lumbar IBF SystemVy Spine, LLC20226—
+3K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+3K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+3K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+3K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+3K211740DualXAmplify Surgical, Inc.20211—
+3K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+3K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+3K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+3K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+3K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+3K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+3K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+3K201671A-Link ZAcuity Surgical Devices, LLC202125—
+3K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+3K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+3K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+3K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+3K203444BEE HA CageNGMedical GmbH20211—
+3K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+3K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+3K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+3K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+3K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+3K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+3K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+3K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+3K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+3K200084Zavation IBF SystemZavation Medical Products, LLC20208—
+3K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+3K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+3K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+3K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+3K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+3K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+3K201585Monterey AL Interbody SystemStryker Corporation202044
+3K201087CORBEL SpacersGlobus Medical, Inc.202036—
+3K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+3K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+3K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—