510(k) Report

Devices descending from K160324

2 later devices reach Cervical Interbody Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+2K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—