510(k) Report

Devices descending from K102641

12 later devices reach Mini and Micro Fragments Reconstruction System-Neoface through their predicates, nearest generation first.

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