510(k) Report

Devices descending from K080401

840 later devices reach Shell Cage, Wave Cage, Loop Cage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+7K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+7K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+7K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+7K192897icotec Cervical CageIcotec AG20201—
+7K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+7K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+7K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+7K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+7K191263Idys ALIF TiVacClariance, Sas20190—
+7K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+7K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+7K172816TiGer Shark™ SystemChoicespine, LP201859—
+7K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+7K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+7K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+7K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+7K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+7K161379ELSA SpacersGlobus Medical, Inc.2016155—
+8K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+8K263049SABER-C SystemElevation Spine20260—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+8K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+8K252742Navigated InstrumentsTyber Medical, LLC20251—
+8K252322SIros-X SystemGenesys Spine20250—
+8K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+8K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+8K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+8K241525ExcelsiusXR™Globus Medical, Inc.20250—
+8K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+8K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+8K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+8K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+8K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+8K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+8K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+8K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+8K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+8K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+8K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+8K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+8K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+8K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+8K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K213417Ghost Spacer SystemLife Spine, Inc.20220—
+8K222561AlignAcuity Surgical Devices, LLC202214—
+8K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+8K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+8K220610SOLO-LAurora Spine, Inc.20220—
+8K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+8K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+8K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+8K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+8K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+8K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+8K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+8K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+8K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+8K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+8K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+8K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+8K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+8K181397DualXInnovasive, Inc.201815—
+8K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+8K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+8K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+8K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+8K171425Concorde LiftMedos International SARL201782
+8K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+9K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+9K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+9K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+9K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+9K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+9K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+9K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+9K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+9K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+9K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+9K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+9K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+9K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+9K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+9K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+9K211740DualXAmplify Surgical, Inc.20211—
+9K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+9K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—