510(k) Report

Devices descending from K140659

483 later devices reach Coroent Thoracolumbar Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+7K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+7K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+7K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+7K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+7K230026SqualeImplanet, S.A.20230—
+7K230583Tryptik TiSpineart SA20231—
+7K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+7K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+7K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+7K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+7K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+7K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+7K222561AlignAcuity Surgical Devices, LLC202214—
+7K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+7K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+7K220610SOLO-LAurora Spine, Inc.20220—
+7K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+7K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+7K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+7K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+7K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+7K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+7K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+7K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+7K200316UNiD IB3D ALIFMedicrea International SA20200—
+7K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+7K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+7K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+7K192897icotec Cervical CageIcotec AG20201—
+7K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+7K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+7K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+8K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+8K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+8K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+8K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+8K250769Dakota LP SystemPrecision Spine, Inc.20250—
+8K252322SIros-X SystemGenesys Spine20250—
+8K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+8K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+8K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+8K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+8K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+8K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+8K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+8K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+8K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+8K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+8K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+8K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+8K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+8K230329F3D Interbody SystemCorelink, LLC20230—
+8K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+8K221578Hexanium ACIFSpinevision, S.A.S.20224—
+8K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+8K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+8K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+8K203003Pantheon IBFDPantheon Spinal20210—
+8K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+9K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+9K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+9K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+9K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+9K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+9K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+10K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+10K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+10K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—