510(k) Report

Devices descending from K001340

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+7K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+7K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+7K183259Idys™ TLIF TiVacClariance, Sas20191—
+7K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+7K190067Velofix Interbody Fusion SystemU&I Corporation20193—
+7K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+7K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+7K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+7K181625Life Spine Resolute™ Threaded Cage SystemLife Spine, Inc.20180—
+7K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+7K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+7K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+7K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+7K182240PASS LP Spinal SystemMedicrea International SA20182—
+7K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+7K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+7K182345Spineology Navigation InstrumentsSpineology, Inc.20182—
+7K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+7K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+7K181014Tritanium PL CageStryker Spine2018137—
+7K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+7K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+7K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+7K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+7K180433Ennovate®Aesculap Implant Systems, LLC201811
+7K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+7K180376K2M Patient Specific RodsK2m, Inc.20182—
+7K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+7K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+7K172828Double Medical Cage SystemDouble Medical Technology, Inc.20181—
+7K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+7K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+7K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+7K173095VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with…Medos International SARL201719—
+7K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+7K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+7K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+7K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+7K171660Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20174—
+7K171651Excelsius GPSGlobus Medical, Inc.2017691
+7K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+7K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+7K171630LumFuse-TPPrecifit Medical, Ltd.20171—
+7K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+7K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+7K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+7K170543VIPER PRIME™ Screws with FenestrationsMedos International SARL201748—
+7K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+7K163491NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2017289—
+7K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+7K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+7K162587Roccia® AcifSilony Medical GmbH20171—
+7K162764Jazz Frame SystemImplanet, S.A.20176—
+7K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG201671
+7K161642CAVUX™ Cervical CageProvidence Medical Technology, Inc.20160—
+7K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201683—
+7K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc.20160—
+7K161369EVEREST Spinal SystemK2m, Incorporated20169—
+7K160715AccuLIF TL and PL CageStryker Corporation20160—
+7K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+7K160926F1 MPS Modular Pedicle Screw SystemDegen Medical20161—
+7K153517AnyPlus® Cervical PEEK Cage SystemGS Medical Co., Ltd.201612—
+7K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+7K153629ArcadiusXP C Spinal SystemAesculap Implant Systems, Inc.20167—
+7K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+7K153783SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIFSpinevision S.A.201613—
+7K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+7K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+7K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201587—
+7K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+7K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+7K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+7K151785Px HA PEEK IBF SystemInnovasis, Inc.201557—
+7K151677LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20158—
+7K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+7K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+7K150231Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc.2015242—
+7K150152The Octane Straight Intervertebral Fusion Device, Ti CoatedExactech, Inc.201510—
+7K150954Elite L Expandable Lumbar Fusion SystemInnova Spinal Technologies, LLC20156—
+7K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201584—
+7K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+7K140734Nextgen Altius Oct SystemEbi, LLC20140—
+7K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+7K1421124WEB Spinal Implant Products4Web, Inc.201433—
+7K141217Acculif TL and PL CageStryker Corporation20146423
+7K132765PFX Spinous Process Fixation SystemInnovasis, Inc.20140—
+7K133556Virage Oct Spinal Fixation SystemZimmer Spine, Inc.2014272
+7K134038Camber Spine Diagon Oblique CageCamber Spine201428—
+7K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+7K131449Coalition SpacerGlobus Medical, Inc.2013235—
+7K122957Tezo Titanium Cage FamilyUlrich GmbH & Co. KG20130—
+7K123997TRANS1LATERAL Interbody Fusion SystemTrans1, Inc.2013173—
+7K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+7K121877Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod…Exactech, Inc.20134—
+7K112700Frontier Sadl Interbody Fusion DeviceFrontier Medical Devices, Inc.20121—
+7K122085Stingray Cervical CageOmni Surgical, LP Dba Spine36020120—
+7K122378Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)201271
+7K121892Phantom Plus Ceramic Cage SystemAmedica Corp.20127—
+7K120991TRANS1 Interbody Fusion SystemTrans1 Incorporated2012172—