510(k) Report

Devices descending from K091644

15 later devices reach Synthes (Usa) 2.4MM LCP Volar Column Distal Radius Plates through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223150APS Metal Plate & Screw SystemA Plus Biotechnology Co., Ltd.20230—
+1K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+1K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A20148—
+1K140107Emerge Medical Distal Radius SetEmerge Medical20140—
+1K120015Osteomed Wrist Plating SystemOsteomed LP20122—
+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—
+2K152145OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20151—
+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—
+3K161041OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20160—