510(k) Report

Devices descending from K001340

2,423 later devices reach Stackable Cage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+6K191263Idys ALIF TiVacClariance, Sas20190—
+6K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+6K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+6K190376PASS LP Spinal SystemMedicrea International SA201915
+6K182349Concorde LiftMedos International SARL20190—
+6K190380nvcNvision Biomedical Technologies, Inc.20193—
+6K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+6K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+6K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+6K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+6K180228II-Type Intervertebral SpacerPaonan Biotech Co., Ltd.20191—
+6K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+6K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+6K181140Axis Chena Cervical PEEK Spacer SystemAxis Orthopaedics20182—
+6K181963ostaPek Interbody Fusion CagesColigne AG20181—
+6K181590Neurostructures Cavetto® [MAX] Cervical Cage SystemNeurostructures, Inc.20180—
+6K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+6K181980OsseoScrew SystemAlphatec Spine, Inc.20181—
+6K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+6K181380LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201810—
+6K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+6K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+6K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+6K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC20186—
+6K173487CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201841—
+6K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+6K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+6K181203Juliet TiSpineart20181—
+6K172788MONET™ Anterior Cervical Interbody Fusion Cage SystemCtl Medical Corporation20181—
+6K180674EVOL® ha-C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20183—
+6K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+6K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+6K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+6K172484A-CIFT SoloFuseSpinefrontier, Inc.201871
+6K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+6K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+6K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+6K172947HALF DOME Posterior Lumbar Interbody SystemAstura Medical201822—
+6K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+6K180324Patriot Spinal Fixation SystemValorus Spine20180—
+6K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+6K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw…Globus Medical, Inc.20184—
+6K180431Cortina [MAX] Lumbar Cage SystemNeurostructures, Inc.20181—
+6K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+6K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+6K172115Navigated Instrument SystemOrthofix, Inc.20184—
+6K173324ALTA Anterior Cervical Interbody SpacerAstura Medical201827—
+6K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+6K173537Concorde Lift™Medos International SARL20181—
+6K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+6K172816TiGer Shark™ SystemChoicespine, LP201859—
+6K172212MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™Ctl Medical Corporation20181—
+6K173508Everest Spinal SystemK2m20189—
+6K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+6K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+6K172623NuVasive Navigation InstrumentsNu Vasive, Incorporated20176—
+6K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+6K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+6K172756Varian cageMedyssey USA, Inc.20171—
+6K173126Arisstos™ Spinal SystemIngenium Spine20171—
+6K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+6K172469TiLock Modular Spinal SystemGenesys Spine20170—
+6K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+6K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies20176—
+6K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+6K171938KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw SetMedtronic201764—
+6K171489Acapella Cervical Spacer SystemChoicespine, LP201739—
+6K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+6K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+6K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+6K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+6K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+6K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+6K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+6K171749Velofix (tm) Interbody Fusion SystemU&I Corporation20175—
+6K170550Coveris Cervical Cage SystemCamber Spine Technologies20171—
+6K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+6K163506Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar…Vertera, Inc.2017224—
+6K170569SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201782—
+6K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+6K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+6K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+6K162496Foundation 3D InterbodyCorelink, LLC201782—
+6K162236Ax Stand-Alone ALIF SystemInnovasis, Inc.201774—
+6K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+6K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+6K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+6K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+6K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemSurgtech, Inc.20170—
+6K162921Navigated Instrument SystemOrthofix, Inc.20175—
+6K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+6K163543Biomet Fusion SystemZimmer Biomet Spine, Inc.2017124—
+6K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+6K162786PASS LP Spinal SystemMedicrea International SA20176—
+6K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education20160—
+6K160879CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsMedos International Sàrl2016106—
+6K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+6K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+6K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—