510(k) Report

Devices descending from K161405

4 later devices reach Valeo II Interbody Fusion Device System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+1K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+2K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+3K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—