510(k) Report

Devices descending from K131122

269 later devices reach S128 Anterior Lumbar Interbody Fusion (Alif) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+10K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+10K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+10K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+10K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+10K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+10K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+10K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+10K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+10K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+10K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+10K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+10K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+10K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+10K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+10K223494CD Horizon Spinal SystemMedtronic202317—
+10K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+10K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+10K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+10K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+10K213417Ghost Spacer SystemLife Spine, Inc.20220—
+10K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+10K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+10K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+10K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+10K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+10K201287Impulse Interbody Fusion SystemDegen Medical20208—
+10K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+10K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+10K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+10K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+10K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+11K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+11K261279DeltaNEC Interbody SystemNexus Spine20260—
+11K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+11K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+11K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+11K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+11K252742Navigated InstrumentsTyber Medical, LLC20251—
+11K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+11K253331PressON Spinal Fixation SystemNexus Spine20250—
+11K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+11K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+11K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+11K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+11K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+11K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+11K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+11K223418DeGen Impulse AM™ SystemDegen Medical20236—
+11K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+11K212358Romero Cervical CageSpineup, Inc.20226—
+11K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+12K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+12K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+12K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+12K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+12K252322SIros-X SystemGenesys Spine20250—
+12K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+12K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+12K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+12K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+12K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+12K230026SqualeImplanet, S.A.20230—
+13K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+13K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+13K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+13K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+14K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+14K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—