510(k) Report

Devices descending from K063052

16 later devices reach Lorenz Titanium Fracture / Reconstruction Devices and Pre-Bent Plates through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131674Prebent Plating with Virtual Surgical PlanningBiomet Microfixation20130—
+1K102641Mini and Micro Fragments Reconstruction System-NeofaceNeoortho Produtos Ortopedicos S/A201012—
+1K080694Osteomed Modular Locking Fixation SystemOsteomed LP20082—
+2K182609Delphos Implants Rigid Fixation SystemDelphos Implants - Ind.Com. Importacao E Exportacao DE20190—
+2K180204CranioMaxillofacial Fixation (CMF) System - CMF VisionareVisionare, LLC20182—
+2K143338Argulated Locking PlatesOsteomed LP20150—
+2K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A20148—
+3K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+3K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+3K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+3K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+3K182758MCI - CMF SystemMci Medical Concept Innovation, Inc.20190—
+4K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+4K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+4K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+4K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—