510(k) Report

Devices descending from K013841

16 later devices reach 3DFIS, Model Ies-FL-101 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123226LessraySaferay Spine, LLC201215—
+2K142243LessRay with TrackingSaferay Spine, LLC201413—
+2K132970LessraySaferay Spine, LLC201314—
+3K173314LessRay SystemNu Vasive, Incorporated20174—
+3K170800NuVasive LessRay with Enhanced TrackingNu Vasive, Incorporated201712—
+4K240199IntraOp Alignment SystemAlphatec Spine, Inc.20241—
+4K230185ANT-X SystemNdr Medical Technology Pte., Ltd.20230—
+4K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+4K173736TrackXTrack X Technology, LLC201832
+5K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+5K251992ArmSure Fluoroscopic Positioning SystemSavfe Co., Ltd.20260—
+5K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+5K200360TrackXTrack X Technology, LLC202022
+6K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+6K230989Rod Registration FrameNu Vasive, Incorporated20230—
+6K213768Bolt Navigation SystemCircinus Medical Technology, LLC20220—