510(k) Report

Devices descending from K072791

1,055 later devices reach Oracle Spacer, Opal Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+5K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+5K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+5K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+5K222561AlignAcuity Surgical Devices, LLC202214—
+5K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+5K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+5K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.20224—
+5K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+5K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+5K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+5K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+5K220610SOLO-LAurora Spine, Inc.20220—
+5K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+5K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+5K212477EARP Interbody SystemNvision Biomedical Technologies, Inc.20221—
+5K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+5K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+5K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+5K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+5K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+5K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+5K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+5K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+5K211740DualXAmplify Surgical, Inc.20211—
+5K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+5K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+5K211413BEE PLIF CageNGMedical GmbH20211—
+5K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+5K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+5K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+5K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+5K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+5K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+5K203003Pantheon IBFDPantheon Spinal20210—
+5K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+5K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+5K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+5K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+5K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+5K203444BEE HA CageNGMedical GmbH20211—
+5K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+5K200429BEE CagesNGMedical GmbH202111—
+5K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+5K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+5K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+5K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+5K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+5K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+5K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+5K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+5K200084Zavation IBF SystemZavation Medical Products, LLC20208—
+5K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+5K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+5K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+5K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+5K201087CORBEL SpacersGlobus Medical, Inc.202036—
+5K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+5K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+5K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+5K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+5K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+5K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+5K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+5K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+5K193258ProLift Expandable SystemLife Spine, Inc.20203—
+5K192993Scarlet AL-TSpineart20201—
+5K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+5K193174Keos Lumbar IBFDKeos20190—
+5K190721LongBow TiLife Spine, Inc.20190—
+5K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+5K191134IB3D AlifMedicrea International SA20191—
+5K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+5K1803473d CageFims Co., Ltd.20190—
+5K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+5K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+5K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+5K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+5K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+5K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+5K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+5K190885Elevation Spine Saber-C SystemElevation Spine201925—
+5K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+5K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+5K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+5K183243Velofix TLIF CageU&I Corporation20190—
+5K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+5K183064TxTi IBF SystemInnovasis, Inc.2019481
+5K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+5K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+5K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+5K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+5K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+5K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+5K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+5K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+5K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+5K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+5K180909REVEL SpacersGlobus Medical, Inc.201837—
+5K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—