510(k) Report

Devices descending from K101310

480 later devices reach VU Apod Intervertebral Body Fusion Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+7K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+7K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+7K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+7K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+7K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+7K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+7K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+7K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+7K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+7K250769Dakota LP SystemPrecision Spine, Inc.20250—
+7K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+7K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+7K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+7K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+7K253331PressON Spinal Fixation SystemNexus Spine20250—
+7K243474MagnetOs MISKuros Biosciences B.V20250—
+7K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+7K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+7K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+7K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+7K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+7K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+7K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+7K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+7K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+7K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+7K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+7K240453ReBOSSISOrthorebirth Co., Ltd.202402
+7K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+7K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+7K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+7K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+7K223418DeGen Impulse AM™ SystemDegen Medical20236—
+7K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+7K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+7K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+7K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+7K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+7K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+7K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+7K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+7K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+7K202637F3D Corpectomy SystemCorelink, LLC20201—
+7K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+7K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+7K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+7K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+7K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+7K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+7K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+7K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+8K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+8K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+8K252742Navigated InstrumentsTyber Medical, LLC20251—
+8K252322SIros-X SystemGenesys Spine20250—
+8K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+8K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+8K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+8K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+8K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+8K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+8K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+8K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+8K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+8K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+8K203003Pantheon IBFDPantheon Spinal20210—
+9K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+9K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+9K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+10K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+10K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+11K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—