510(k) Report

Devices descending from K112812

11 later devices reach Leforte Neuro System Bone Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170368Sterile NS SystemJeil Medical Corporation20170—
+1K141911Optimus Neuro SystemOsteonic Co., Ltd.20154—
+1K141644Innovasis Cranial SystemInnovasis, Inc.20140—
+1K141452Leforte Neuro System Bone Plate and ScrewJeil Medical Corporation20144—
+2K212391MCI-Neuro Fixation SystemMci Medical Concept Innovation, Inc.20220—
+2K210099Meticuly Patient-Specific Titanium Mesh ImplantMeticuly Co., Ltd.20212—
+2K190811Optimus NEURO System - Sterile KitOsteonic Co., Ltd.20191—
+2K183352Optimus Neuro SystemOsteonic Co., Ltd.20192—
+3K252251Easymade-TICG Bio Co., Ltd.20260—
+3K252958METICULY Patient-specific titanium mesh implantMeticuly Co., Ltd.20260—
+3K210360Neuro Plating System, Neuro Plating System Plates (NST304M02A and 61 Models), Neuro…Osteonic Co., Ltd.20220—