510(k) Report

Devices descending from K093669

744 later devices reach Sec Ibf Cage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+8K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+8K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+8K172941CASCADIA Interbody SystemK2m201852—
+8K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+8K172009Cascadia Interbody SystemK2m, Inc.2017433
+8K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+8K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+8K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+8K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+8K171704CAPRI Corpectomy Cage SystemK2m201710—
+8K171425Concorde LiftMedos International SARL201782
+8K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+8K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+9K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+9K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+9K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+9K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+9K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+9K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+9K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+9K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+9K242589Scarlet® AL-TSpineart SA20240—
+9K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+9K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+9K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+9K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+9K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+9K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+9K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+9K240442MagnetOs PuttyKuros Biosciences B.V20243—
+9K234150Lucent® XPSpinal Elements20240—
+9K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+9K232347MagnetOs GranulesKuros Biosciences B.V20242—
+9K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+9K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+9K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+9K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+9K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+9K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+9K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+9K232315Catalyst Bone Void FillerOssdsign AB20237—
+9K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+9K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+9K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+9K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+9K223251Hexanium PLIFSpinevision, S.A.S.20220—
+9K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+9K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+9K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+9K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+9K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+9K203003Pantheon IBFDPantheon Spinal20210—
+9K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+9K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+9K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+9K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+9K202637F3D Corpectomy SystemCorelink, LLC20201—
+9K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+9K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+9K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+9K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+9K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+9K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+9K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+9K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+9K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+9K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+9K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+9K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+9K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+9K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+9K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+9K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+9K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+9K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+9K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+9K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+9K182349Concorde LiftMedos International SARL20190—
+9K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+9K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+9K173537Concorde Lift™Medos International SARL20181—
+10K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+10K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+10K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+10K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+10K253545Vulcan Spinal SystemK2m, Inc.20260—
+10K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+10K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+10K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+10K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+10K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+10K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+10K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+10K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+10K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+10K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+10K240453ReBOSSISOrthorebirth Co., Ltd.202402
+10K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—