510(k) Report

Devices descending from K233951

5 later devices reach CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+1K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+2K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+2K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+3K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—