510(k) Report

Devices descending from K012254

2,058 later devices reach VBR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+7K223764INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc.20230—
+7K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+7K223273ASTRA Spine SystemSpinecraft, LLC20228—
+7K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+7K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+7K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+7K223251Hexanium PLIFSpinevision, S.A.S.20220—
+7K223510Matrix HA Fusion Porous Cervical IBF SystemInnovasis, Inc.20220—
+7K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+7K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+7K221578Hexanium ACIFSpinevision, S.A.S.20224—
+7K220334MONET Anterior Cervical Plate SystemCtl Medical Corporation20220—
+7K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+7K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+7K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+7K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+7K222561AlignAcuity Surgical Devices, LLC202214—
+7K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+7K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+7K221745Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co, Ltd.20220—
+7K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.20224—
+7K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+7K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+7K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+7K221844TDM Lumbar Interbody Fusion Cage SystemTdm Co., Ltd.20221—
+7K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+7K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+7K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+7K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+7K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+7K220610SOLO-LAurora Spine, Inc.20220—
+7K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+7K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+7K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+7K212477EARP Interbody SystemNvision Biomedical Technologies, Inc.20221—
+7K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+7K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+7K220131KYPHON VuE Bone CementTecres S.P.A.20220—
+7K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+7K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+7K220025ARx® Spinal SystemLife Spine, Inc.20220—
+7K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+7K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+7K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+7K213918DeGen Navigated InstrumentationDegen Medical20220—
+7K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+7K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+7K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+7K210573Velofix SA Cervical CageU&I Corporation20211—
+7K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+7K211740DualXAmplify Surgical, Inc.20211—
+7K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+7K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+7K201793EDEN Peek CageJmt Co., Ltd.20210—
+7K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+7K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+7K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+7K211413BEE PLIF CageNGMedical GmbH20211—
+7K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+7K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+7K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+7K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+7K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+7K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+7K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+7K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+7K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+7K210549ARx Spinal SystemLife Spine, Inc.20211—
+7K200919Idys ALIF 3DTiClariance20210—
+7K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+7K202032Idys LLIF 3DTiClariance, Sas20210—
+7K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+7K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+7K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+7K200429BEE CagesNGMedical GmbH202111—
+7K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+7K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+7K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+7K203452Nano FortiFix® SystemNanovis, LLC20200—
+7K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+7K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+7K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+7K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+7K200316UNiD IB3D ALIFMedicrea International SA20200—
+7K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+7K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+7K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+7K200084Zavation IBF SystemZavation Medical Products, LLC20208—
+7K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+7K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+7K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+7K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+7K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+7K201831CONFIDENCE Spinal Cement SystemDepuy Spine, Inc.20200—
+7K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+7K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+7K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+7K200322Altus Spine Pedicle Screw SystemAltus Partners, LLC20204—
+7K200920Idys ALIF ZP 3DTiClariance, Sas20203—