510(k) Report

Devices descending from K141383

6 later devices reach Acumed Hand Fracture System through their predicates, nearest generation first.

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