510(k) Report

Devices descending from K123767

324 later devices reach Lanx Fusion System- SA through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+11K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+11K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+12K261279DeltaNEC Interbody SystemNexus Spine20260—
+12K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+12K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+12K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+12K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+12K252742Navigated InstrumentsTyber Medical, LLC20251—
+12K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+12K253331PressON Spinal Fixation SystemNexus Spine20250—
+12K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+12K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+12K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+12K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+12K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+13K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+13K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+13K252322SIros-X SystemGenesys Spine20250—
+13K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+13K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+13K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+14K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+15K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—