510(k) Report

Devices descending from K001238

15 later devices reach Lorenz Titanium Fracture / Reconstruction Plating System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081067Fracture/Reconstruction System (Traumaone)Biomet Microfixation, Inc.200814—
+2K131674Prebent Plating with Virtual Surgical PlanningBiomet Microfixation20130—
+2K102641Mini and Micro Fragments Reconstruction System-NeofaceNeoortho Produtos Ortopedicos S/A201012—
+3K180204CranioMaxillofacial Fixation (CMF) System - CMF VisionareVisionare, LLC20182—
+3K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A20148—
+4K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+4K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+4K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+4K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+4K182758MCI - CMF SystemMci Medical Concept Innovation, Inc.20190—
+4K182609Delphos Implants Rigid Fixation SystemDelphos Implants - Ind.Com. Importacao E Exportacao DE20190—
+5K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+5K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+5K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+5K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—