510(k) Report

Devices descending from K221728

1 later device reach Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—