510(k) Report

Devices descending from K090522

15 later devices reach Osteomed Hand Plate and Screw Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+1K132769Acumed Hand Plating SystemAcumed, LLC20147—
+1K120015Osteomed Wrist Plating SystemOsteomed LP20122—
+1K111419Osteomed Hand Fusion SystemOsteomed LP20111—
+2K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+2K152145OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20151—
+2K141383Acumed Hand Fracture SystemAcumed, LLC20146—
+2K130120Extremity Medical IP Fusion SystemExtremity Medical, LLC20130—
+3K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+3K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+3K161041OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20160—
+4K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+4K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+5K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+5K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—