510(k) Report

Devices descending from K100205

5 later devices reach Frontier Devices Neuro System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141911Optimus Neuro SystemOsteonic Co., Ltd.20154—
+2K212391MCI-Neuro Fixation SystemMci Medical Concept Innovation, Inc.20220—
+2K190811Optimus NEURO System - Sterile KitOsteonic Co., Ltd.20191—
+2K183352Optimus Neuro SystemOsteonic Co., Ltd.20192—
+3K210360Neuro Plating System, Neuro Plating System Plates (NST304M02A and 61 Models), Neuro…Osteonic Co., Ltd.20220—