510(k) Report

Devices descending from K142095

254 later devices reach Renovis S134 Anterior Lumbar Interbody Fusion (Alif) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+8K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+8K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+8K213417Ghost Spacer SystemLife Spine, Inc.20220—
+8K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+8K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+8K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+8K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+8K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+8K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+8K201287Impulse Interbody Fusion SystemDegen Medical20208—
+8K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+8K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+8K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+8K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+8K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+9K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+9K261279DeltaNEC Interbody SystemNexus Spine20260—
+9K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+9K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+9K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+9K252742Navigated InstrumentsTyber Medical, LLC20251—
+9K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+9K253331PressON Spinal Fixation SystemNexus Spine20250—
+9K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+9K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+9K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+9K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+9K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+9K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+9K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+9K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+9K223418DeGen Impulse AM™ SystemDegen Medical20236—
+9K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+9K212358Romero Cervical CageSpineup, Inc.20226—
+9K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+10K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+10K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+10K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+10K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+10K252322SIros-X SystemGenesys Spine20250—
+10K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+10K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+10K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+10K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+10K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+10K230026SqualeImplanet, S.A.20230—
+11K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+11K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+11K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+11K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+12K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+12K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—