510(k) K261830

FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog) by Ortler Global Tibbi Gerecler Anonim Sirketi — Product Code HRS

K261830 is an FDA 510(k) premarket notification submitted by Ortler Global Tibbi Gerecler Anonim Sirketi for the device "FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)". The FDA issued a decision of Substantially Equivalent on August 28, 2026. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Ortler Global Tibbi Gerecler Anonim Sirketi has at least 1 other 510(k) clearance on record.