510(k) Report

Devices descending from K052746

1,149 later devices reach Concorde VBR Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+5K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+5K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+5K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+5K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+5K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+5K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+5K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+5K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+5K223143SAGICO Spinal SystemSagico VA USA, LLC20230—
+5K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+5K231359RODIN™ Expandable Lumbar Cage SystemCtl Medical Corporation20230—
+5K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+5K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+5K223430ProLift Micro Expandable Spacer SystemLife Spine, Inc.20236—
+5K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+5K223326Axiom PSR SystemRestor3D202301
+5K230026SqualeImplanet, S.A.20230—
+5K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+5K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+5K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+5K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+5K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+5K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+5K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+5K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+5K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+5K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+5K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+5K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+5K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+5K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+5K221578Hexanium ACIFSpinevision, S.A.S.20224—
+5K220334MONET Anterior Cervical Plate SystemCtl Medical Corporation20220—
+5K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+5K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+5K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+5K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+5K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+5K222797X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20221—
+5K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+5K213417Ghost Spacer SystemLife Spine, Inc.20220—
+5K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+5K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+5K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+5K221687Pegasus-X Expandable PLIF SystemGS Medical Co., Ltd.20220—
+5K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+5K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+5K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+5K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+5K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+5K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+5K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+5K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+5K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+5K213441PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20222—
+5K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+5K212930LumiVy Lumbar IBF SystemVy Spine, LLC20226—
+5K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+5K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+5K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+5K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+5K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+5K212562Idys-C ZP 3DTiClariance, SA20211—
+5K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+5K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+5K211689KEYSTONE PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20212—
+5K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+5K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+5K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+5K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+5K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+5K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+5K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+5K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+5K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+5K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+5K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+5K201671A-Link ZAcuity Surgical Devices, LLC202125—
+5K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+5K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+5K203444BEE HA CageNGMedical GmbH20211—
+5K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+5K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+5K210359Hexanium TLIFSpinevision, S.A.S.20211—
+5K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+5K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+5K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+5K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+5K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+5K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+5K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+5K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+5K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+5K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+5K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+5K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+5K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—