510(k) Report

Devices descending from P980048

1,422 later devices reach Bak/Cervical (Bak/C) Interbody Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+5K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+5K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+5K222833Ventana™ C Spinal SystemSpinal Elements, Inc.20234—
+5K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+5K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+5K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+5K230808PEEK SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20230—
+5K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+5K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+5K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+5K223494CD Horizon Spinal SystemMedtronic202317—
+5K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+5K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+5K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+5K223510Matrix HA Fusion Porous Cervical IBF SystemInnovasis, Inc.20220—
+5K212612Omnia Medical TiBrid-SCOmnia Medical, LLC20220—
+5K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+5K223065Adcura® Sagittae® Lateral Lumbar Interbody Fusion DevicesAdcura, Inc.20220—
+5K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+5K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+5K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+5K222561AlignAcuity Surgical Devices, LLC202214—
+5K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+5K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.20224—
+5K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+5K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+5K220610SOLO-LAurora Spine, Inc.20220—
+5K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+5K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+5K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+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—
+5K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+5K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+5K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+5K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+5K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+5K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+5K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+5K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+5K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+5K200919Idys ALIF 3DTiClariance20210—
+5K202032Idys LLIF 3DTiClariance, Sas20210—
+5K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+5K210359Hexanium TLIFSpinevision, S.A.S.20211—
+5K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+5K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+5K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+5K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+5K202230NEXXT MATRIXX Stand Alone ALIF SystemNexxt Spine, LLC20200—
+5K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+5K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+5K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+5K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+5K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+5K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+5K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+5K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+5K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+5K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+5K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+5K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+5K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+5K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+5K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+5K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+5K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+5K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+5K193320KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20203—
+5K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+5K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+5K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+5K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+5K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+5K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+5K190488ProLift Expandable SystemLife Spine, Inc.201916—
+5K190680Favo S-TlifSilony Medical GmbH20190—
+5K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+5K182608Oyster ACIF CageSilony Medical GmbH20190—
+5K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+5K191263Idys ALIF TiVacClariance, Sas20190—
+5K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+5K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+5K190147COLOSSEUM MeshGlobus Medical, Inc.20190—
+5K190655SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201974—
+5K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+5K190055Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20191—
+5K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+5K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+5K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+5K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+5K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+5K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201828—
+5K173982FORTIFY Corpectomy SpacersGlobus Medical, Inc.20188—
+5K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+5K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+5K180673Normandy VBR SystemZavation Medical Products, LLC20187—
+5K181203Juliet TiSpineart20181—