510(k) Report

Devices descending from K001340

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+5K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+5K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+5K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+5K202771CD Horizon Spinal SystemMedtronic202021—
+5K200084Zavation IBF SystemZavation Medical Products, LLC20208—
+5K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+5K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+5K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+5K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+5K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+5K201145X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20204—
+5K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+5K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+5K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+5K201087CORBEL SpacersGlobus Medical, Inc.202036—
+5K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+5K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+5K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+5K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+5K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+5K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+5K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+5K200312Tryptik TiSpineart20202—
+5K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+5K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+5K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+5K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+5K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+5K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+5K193258ProLift Expandable SystemLife Spine, Inc.20203—
+5K193645nva, nvp, and nvtNvision Biomedical Technologies, Inc.20203—
+5K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+5K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+5K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+5K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+5K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+5K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+5K191796Neo Cage SystemNeo Medical SA20190—
+5K191118Avanti Distal Radius and Forearm SystemAvanti Orthopaedics, Inc.20191—
+5K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+5K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+5K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+5K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+5K190544XIHPOS™ ZFUZE™ Interbody Fusion SystemDifusion Technologies20190—
+5K192117Small VBR™Ulrich GmbH & Co. KG20196—
+5K191134IB3D AlifMedicrea International SA20191—
+5K1803473d CageFims Co., Ltd.20190—
+5K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC20193—
+5K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+5K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+5K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+5K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+5K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+5K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+5K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+5K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+5K190398Republic Spine Restore Intervertebral Body Fusion SystemRepublic Spine, LLC20190—
+5K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+5K183407Triton CageMedyssey USA, Inc.20190—
+5K191778Omnia Medical VBROmnia Medical, LLC20195—
+5K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+5K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+5K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+5K190885Elevation Spine Saber-C SystemElevation Spine201925—
+5K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+5K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+5K190680Favo S-TlifSilony Medical GmbH20190—
+5K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+5K183243Velofix TLIF CageU&I Corporation20190—
+5K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+5K183064TxTi IBF SystemInnovasis, Inc.2019481
+5K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+5K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+5K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+5K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+5K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+5K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+5K183381Navigation Enabled InstrumentsStryker20191—
+5K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+5K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+5K173518Spectrum Spine Expandable Cages (SSEC)Spectrum Spine, LLC20196—
+5K190055Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20191—
+5K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+5K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+5K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+5K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198—
+5K181048Neo Cage System TMNeo Medical SA20191—
+5K182477Cervical SpacerAdditive Implants, LLC201915—
+5K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+5K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+5K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+5K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+5K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+5K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+5K181829Velofix TLIF CageU&I Corporation20181—
+5K182322Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+5K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+5K181337Sypher Spacer SystemBiogennix, LLC20180—
+5K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—