510(k) Report

Devices descending from K073144

463 later devices reach Lanx Intervertebral Body Fusion Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+9K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+9K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+9K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+9K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+9K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+9K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+9K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+9K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+9K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+9K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+10K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+10K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+10K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+10K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+10K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+10K253260ORIO-3D Cage SystemSpineCraft20260—
+10K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+10K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+10K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+10K252742Navigated InstrumentsTyber Medical, LLC20251—
+10K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+10K253331PressON Spinal Fixation SystemNexus Spine20250—
+10K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+10K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+10K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+10K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+10K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+10K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+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—
+10K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+10K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+10K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+10K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+10K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+10K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+10K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+10K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+11K261408SABER-XA SystemElevation Spine20260—
+11K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+11K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+11K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+11K252322SIros-X SystemGenesys Spine20250—
+11K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+11K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+11K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+11K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+11K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+11K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+11K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+11K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+11K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+11K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+11K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+11K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+12K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+12K261279DeltaNEC Interbody SystemNexus Spine20260—
+12K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+12K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+13K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—