510(k) Report

Devices descending from K001340

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+6K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+6K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+6K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+6K220902Navagio Lumbar CageKalitec Medical, LLC20220—
+6K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+6K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+6K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+6K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+6K212477EARP Interbody SystemNvision Biomedical Technologies, Inc.20221—
+6K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+6K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+6K220655X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20222—
+6K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+6K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+6K212266FIX-C PEEK Anterior Cervical Interbody SystemJeil Medical Corporation20217—
+6K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+6K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+6K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+6K212562Idys-C ZP 3DTiClariance, SA20211—
+6K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+6K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+6K211413BEE PLIF CageNGMedical GmbH20211—
+6K211501Advantage-C PEEK Cervical lnterbody Fusion DeviceLntelivation, LLC20211—
+6K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+6K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+6K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+6K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+6K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+6K211306LabyrinthZavation Medical Products, LLC20213—
+6K201737Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co, Ltd.20211—
+6K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+6K203802X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20213—
+6K211323ASTRA Spine SystemSpinecraft, LLC202112—
+6K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+6K210306GII Spinal Fixation SystemColigne AG20210—
+6K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH20216—
+6K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+6K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+6K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+6K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+6K200919Idys ALIF 3DTiClariance20210—
+6K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+6K203816DeGen Navigated InstrumentationDegen Medical20211—
+6K202032Idys LLIF 3DTiClariance, Sas20210—
+6K210472SPINEART Navigation Instrument SystemSpineart20215—
+6K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+6K210359Hexanium TLIFSpinevision, S.A.S.20211—
+6K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+6K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+6K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+6K200429BEE CagesNGMedical GmbH202111—
+6K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+6K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+6K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+6K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+6K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+6K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+6K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+6K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+6K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+6K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+6K200316UNiD IB3D ALIFMedicrea International SA20200—
+6K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+6K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+6K201769Cavetto [MAX] Cervical Cage SystemNeurostructures, Inc.20200—
+6K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+6K201006K2M Navigation InstrumentsK2m, Inc.20200—
+6K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+6K201648Sterispine™ PSSafe Orthopaedics202011
+6K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+6K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+6K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+6K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+6K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+6K200070ARx Spinal SystemLife Spine, Inc.20209—
+6K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+6K200552EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20200—
+6K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+6K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+6K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+6K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+6K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+6K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+6K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+6K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+6K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+6K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+6K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+6K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+6K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+6K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+6K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+6K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.201950—
+6K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+6K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+6K191575ARx Spinal SystemLife Spine, Inc.201910—
+6K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+6K183091Elaris Pedicle Screw SystemSpinewelding AG20190—
+6K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—