510(k) Report

Devices descending from K953385

25 later devices reach Lorenz 1.0MM, 1.5MM, 2.0MM System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122049Neuropro Low Profile Cranial Plating SystemKinamed, Inc.20130—
+1K121624Biomet Microfixation Neuro Plating SystemBiomet Microfixation201252
+1K121589Biomet Microfixation Facial Plating SystemBiomet Microfixation201251
+1K063386Lorenz Orthodontic Anchorage SystemWalter Lorenz Surgical, Inc.20070—
+1K032520Ortrautek Trauma SystemTekka20030—
+1K031989Ortrautek Orthognathic SystemTekka20035—
+1K010427Lorenz Fiducail ScrewWalter Lorenz Surgical, Inc.20011—
+1K973484Chin DistractorHowmedica, Inc.19971—
+2K182609Delphos Implants Rigid Fixation SystemDelphos Implants - Ind.Com. Importacao E Exportacao DE20190—
+2K160385Precision ScrewCryptych Pty, Ltd.20160—
+2K141911Optimus Neuro SystemOsteonic Co., Ltd.20154—
+2K140037Optimus CMF SystemOsteonic Co., Ltd.20152—
+2K132600Facial Prebent Plating with Virtual Surgical PlanningBiomet Microfixation20130—
+2K091812Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic, Mandible…Frontier Devices, Inc.20104—
+2K030790Osteomed Alveolar Distraction SystemOsteomed LP20030—
+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—
+3K141764Tristar Bone Graft Fixation SystemImpladent, Ltd.20143—
+4K210360Neuro Plating System, Neuro Plating System Plates (NST304M02A and 61 Models), Neuro…Osteonic Co., Ltd.20220—
+4K170697GBR systemSurgident20182—
+5K222367Save GBRDentis Co., Ltd.20230—
+5K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd.20200—