510(k) Report

Devices descending from K003155

2,091 later devices reach Vertebral Body Replacement through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K203452Nano FortiFix® SystemNanovis, LLC20200—
+8K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+8K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+8K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+8K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+8K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+8K200316UNiD IB3D ALIFMedicrea International SA20200—
+8K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+8K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+8K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+8K200084Zavation IBF SystemZavation Medical Products, LLC20208—
+8K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+8K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+8K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+8K201831CONFIDENCE Spinal Cement SystemDepuy Spine, Inc.20200—
+8K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+8K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+8K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+8K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+8K200322Altus Spine Pedicle Screw SystemAltus Partners, LLC20204—
+8K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+8K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+8K200303Reform Pedicle Screw SystemPrecision Spine202010—
+8K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+8K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+8K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+8K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+8K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+8K192818Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemStryker Corporation20208—
+8K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+8K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+8K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+8K193521Steerable Plateau TiLife Spine, Inc.20201—
+8K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+8K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+8K193258ProLift Expandable SystemLife Spine, Inc.20203—
+8K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+8K1920444CIS Marlin PEEK ACIF CageSolco Biomedical Co., Ltd.20190—
+8K193219G Surgical Marksman SystemG Surgical, LLC20191—
+8K193174Keos Lumbar IBFDKeos20190—
+8K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+8K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+8K190721LongBow TiLife Spine, Inc.20190—
+8K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+8K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+8K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+8K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+8K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+8K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+8K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+8K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+8K183064TxTi IBF SystemInnovasis, Inc.2019481
+8K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+8K191263Idys ALIF TiVacClariance, Sas20190—
+8K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+8K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+8K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+8K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+8K173518Spectrum Spine Expandable Cages (SSEC)Spectrum Spine, LLC20196—
+8K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+8K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+8K183259Idys™ TLIF TiVacClariance, Sas20191—
+8K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+8K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+8K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+8K190067Velofix Interbody Fusion SystemU&I Corporation20193—
+8K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+8K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+8K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+8K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+8K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+8K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+8K181829Velofix TLIF CageU&I Corporation20181—
+8K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+8K182322Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+8K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+8K182240PASS LP Spinal SystemMedicrea International SA20182—
+8K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+8K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+8K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+8K182345Spineology Navigation InstrumentsSpineology, Inc.20182—
+8K181380LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201810—
+8K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+8K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+8K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+8K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+8K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+8K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+8K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+8K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+8K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+8K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+8K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+8K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+8K180433Ennovate®Aesculap Implant Systems, LLC201811
+8K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+8K180376K2M Patient Specific RodsK2m, Inc.20182—
+8K173128Alamo® CAlliance Partners, LLC20182—
+8K180431Cortina [MAX] Lumbar Cage SystemNeurostructures, Inc.20181—
+8K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—