510(k) Report

Devices descending from K990148

1,867 later devices reach Stackable Cage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+7K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+7K171749Velofix (tm) Interbody Fusion SystemU&I Corporation20175—
+7K171031CRESCENT™ Spinal SystemMedtronic Sofamor Danek2017144—
+7K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+7K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+7K160856SpineView X-Pac Expandable Lumbar Cage SystemSpine View, Inc.20165—
+7K161028K2M Growing Spine SystemK2m, Inc.20163—
+7K161369EVEREST Spinal SystemK2m, Incorporated20169—
+7K160715AccuLIF TL and PL CageStryker Corporation20160—
+7K153695Biomet Spine Fusion SystemBiomet Spine, LLC201632
+7K151900VariLift-L Interbody Fusion DeviceWenzel Spine, Inc.20158—
+7K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+7K151785Px HA PEEK IBF SystemInnovasis, Inc.201557—
+7K151216Everest Spinal SystemK2m, Inc.201511—
+7K151128CAPSTONE Spinal System, CLYDESDALE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015255—
+7K150152The Octane Straight Intervertebral Fusion Device, Ti CoatedExactech, Inc.201510—
+7K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+7K141896Coroent SystemNu Vasive, Incorporated2014480—
+7K141791Biomet Fusion SystemBiomet Spine2014128—
+7K133577Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2014256—
+7K133402K2M Modular HooksK2m, Inc.20140—
+7K133053Milestone Spinal SystemWeigao Orthopaedic Device Co., Ltd.20142—
+7K140709Skyhawk Interbody Fusion SystemOrthofix, Inc.20147—
+7K140007Abacus TM Spacer SystemSpine Wave, Inc.20144—
+7K130274Biolign Acif Systems, Biolign Stacc Acif System, Biolign Tlif SystemElite Surgical Supplies (Pty), Ltd.20139—
+7K132719Staxx Ibl SystemSpine Wave, Inc.20137—
+7K132505Acculif TL and PL CageCoalign Innovations, Inc.20136453
+7K131296Varilift-L Interbody Fusion DeviceWenzel Spine, Inc.20130—
+7K131540Interfuse L Intervertebral Body Fusion DeviceVertebral Technologies, Inc.20136—
+7K131425Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale InserterMedtronic Navigation, Inc.201324610
+7K131547Lanx Fusion SystemLanx, Inc.20131631
+7K131443Coalign Innovations Acculif XL Ibf CageCoalign Innovations, Inc.20130—
+7K123978Capstone L Spinal SystemMedtronic Sofamor Danek USA201313—
+7K123997TRANS1LATERAL Interbody Fusion SystemTrans1, Inc.2013173—
+7K122047Alamo PAlliance Partners, LLC20120—
+7K113528Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011361—
+7K110562Telamon Peek Spinal SystemMedtronic Sofamor Danek USA2011306—
+7K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011808—
+7K111569Plateau Spacer SystemLife Spine2011181—
+7K100945Fuse Plif CafeAdvanced Medical Technologies AG2011463—
+7K100175Clydesdale Spinal SystemMedtronic Sofamor Danek20101,008—
+7K094025Crescent Spinal SystemMedtronic Sofamor Danek2010838—
+7K091813Intrepid Spinal SystemMedtronic Sofamor Danek2009719—
+7K090353Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2009796—
+7K082801Phantom Plus Cage SystemUs Spine2008643—
+7K082732Modification to: Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008710—
+7K082342Modification to Capstone Spinal SystemMedtronic Sofamor Danek2008716—
+8K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+8K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+8K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+8K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+8K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+8K252322SIros-X SystemGenesys Spine20250—
+8K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+8K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+8K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K242464Stealth™ Spine Clamps; ModuLeX™ Shank MountsMedtronic Navigation, Inc.20251—
+8K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+8K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+8K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+8K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+8K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+8K233075“BioGend” Interbody Fusion System 001 CageBiogend Therapeutics Co., Ltd.20240—
+8K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+8K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+8K230989Rod Registration FrameNu Vasive, Incorporated20230—
+8K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+8K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+8K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+8K211442StealthStation Spinous Process ClampsMedtronic Navigation20212—
+8K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+8K210728CONDUIT InstrumentsMedos International SARL20215—
+8K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+8K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+8K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+8K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+8K190067Velofix Interbody Fusion SystemU&I Corporation20193—
+8K181625Life Spine Resolute™ Threaded Cage SystemLife Spine, Inc.20180—
+8K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+8K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+8K181188EVEREST Spinal SystemK2m, Inc.20186—
+8K172828Double Medical Cage SystemDouble Medical Technology, Inc.20181—
+8K171321K2M Navigation InstrumentsK2m201711
+8K171630LumFuse-TPPrecifit Medical, Ltd.20171—
+8K163543Biomet Fusion SystemZimmer Biomet Spine, Inc.2017124—
+8K160074Rampart D Lumbar Interbody Fusion DeviceSpineology, Inc.20165—
+8K153517AnyPlus® Cervical PEEK Cage SystemGS Medical Co., Ltd.201612—
+8K153629ArcadiusXP C Spinal SystemAesculap Implant Systems, Inc.20167—
+8K153783SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIFSpinevision S.A.201613—
+8K160418PERIMETER Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.20165—
+8K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+8K150231Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc.2015242—
+8K150954Elite L Expandable Lumbar Fusion SystemInnova Spinal Technologies, LLC20156—
+8K141217Acculif TL and PL CageStryker Corporation20146423