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)

510(k) 号: K261830
器械名称: 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)
申请人: Ortler Global Tibbi Gerecler Anonim Sirketi TR
产品代码: HRS — Plate, Fixation, Bone
批准日期: 2026-08-28
受理日期: 2026-06-02
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: Orthopedic

PDF下载 510(k) Summary本站存档 · 1.6 MB · FDA 公有领域文件

也可从 FDA 官方下载： K261830.pdf

FDA 官方记录： K261830

数据来自 openFDA 510(k) 数据集（CC0 公有领域），以 FDA 现行记录为准。510(k) 许可不等于 FDA 认证或批准。