510(k) Report

Devices descending from K132769

7 later devices reach Acumed Hand Plating System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141383Acumed Hand Fracture SystemAcumed, LLC20146—
+2K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+2K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+3K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+3K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+4K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+4K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—