510(k) Report

Devices descending from K183352

2 later devices reach Optimus Neuro System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190811Optimus NEURO System - Sterile KitOsteonic Co., Ltd.20191—
+2K210360Neuro Plating System, Neuro Plating System Plates (NST304M02A and 61 Models), Neuro…Osteonic Co., Ltd.20220—