510(k) Report

Devices descending from K922741

12 later devices reach Lorenz 1.0 MM System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121624Biomet Microfixation Neuro Plating SystemBiomet Microfixation201252
+1K121589Biomet Microfixation Facial Plating SystemBiomet Microfixation201251
+2K182609Delphos Implants Rigid Fixation SystemDelphos Implants - Ind.Com. Importacao E Exportacao DE20190—
+2K141911Optimus Neuro SystemOsteonic Co., Ltd.20154—
+2K140037Optimus CMF SystemOsteonic Co., Ltd.20152—
+2K132600Facial Prebent Plating with Virtual Surgical PlanningBiomet Microfixation20130—
+3K253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty), Ltd.20250—
+3K212391MCI-Neuro Fixation SystemMci Medical Concept Innovation, Inc.20220—
+3K190811Optimus NEURO System - Sterile KitOsteonic Co., Ltd.20191—
+3K183352Optimus Neuro SystemOsteonic Co., Ltd.20192—
+3K160363Optimus CMF SystemOsteonic Co., Ltd.20160—
+4K210360Neuro Plating System, Neuro Plating System Plates (NST304M02A and 61 Models), Neuro…Osteonic Co., Ltd.20220—