510(k) Report

Devices descending from K243007

3 later devices reach CD Horizon™ Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+1K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+2K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—