510(k) Report

Devices descending from K072758

6 later devices reach Synthes (Usa) 2.0MM Titanium T-Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100205Frontier Devices Neuro SystemFolsom Metal Products, Inc.20105—
+2K141911Optimus Neuro SystemOsteonic Co., Ltd.20154—
+3K212391MCI-Neuro Fixation SystemMci Medical Concept Innovation, Inc.20220—
+3K190811Optimus NEURO System - Sterile KitOsteonic Co., Ltd.20191—
+3K183352Optimus Neuro SystemOsteonic Co., Ltd.20192—
+4K210360Neuro Plating System, Neuro Plating System Plates (NST304M02A and 61 Models), Neuro…Osteonic Co., Ltd.20220—