510(k) Report

Devices descending from K141911

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212391MCI-Neuro Fixation SystemMci Medical Concept Innovation, Inc.20220—
+1K190811Optimus NEURO System - Sterile KitOsteonic Co., Ltd.20191—
+1K183352Optimus Neuro SystemOsteonic Co., Ltd.20192—
+2K210360Neuro Plating System, Neuro Plating System Plates (NST304M02A and 61 Models), Neuro…Osteonic Co., Ltd.20220—