510(k) Report

Devices descending from K161634

3 later devices reach IPS CaseDesigner through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212981MirrorMe3D Modeling SystemMirrorme3D, LLC20220—
+1K200810IPS CaseDesignerNobel Biocare AB20201—
+2K230276TECHFIT DISRP® SystemTechfit Digital Surgery20230—