510(k) Report

Devices descending from K072415

948 later devices reach Stalif (TM) C through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+4K223065Adcura® Sagittae® Lateral Lumbar Interbody Fusion DevicesAdcura, Inc.20220—
+4K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+4K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+4K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+4K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+4K222561AlignAcuity Surgical Devices, LLC202214—
+4K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+4K220610SOLO-LAurora Spine, Inc.20220—
+4K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+4K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+4K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+4K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+4K212358Romero Cervical CageSpineup, Inc.20226—
+4K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+4K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+4K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+4K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+4K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+4K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+4K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+4K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+4K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+4K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+4K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+4K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+4K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+4K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+4K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+4K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+4K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+4K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+4K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+4K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+4K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+4K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+4K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+4K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+4K210359Hexanium TLIFSpinevision, S.A.S.20211—
+4K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+4K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+4K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+4K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+4K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+4K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+4K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+4K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+4K202230NEXXT MATRIXX Stand Alone ALIF SystemNexxt Spine, LLC20200—
+4K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+4K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+4K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+4K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+4K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+4K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+4K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+4K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+4K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+4K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+4K201087CORBEL SpacersGlobus Medical, Inc.202036—
+4K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+4K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+4K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+4K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+4K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+4K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+4K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+4K200312Tryptik TiSpineart20202—
+4K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+4K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+4K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+4K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+4K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+4K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+4K193320KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20203—
+4K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+4K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+4K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+4K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+4K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+4K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+4K191134IB3D AlifMedicrea International SA20191—
+4K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+4K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+4K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+4K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+4K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+4K183407Triton CageMedyssey USA, Inc.20190—
+4K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+4K190885Elevation Spine Saber-C SystemElevation Spine201925—
+4K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+4K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+4K190680Favo S-TlifSilony Medical GmbH20190—
+4K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+4K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+4K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+4K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+4K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+4K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+4K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+4K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043