K253080

AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)

510(k) 号: K253080
器械名称: AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)
申请人: Suzhou and Science & Technology Development Corp. CN
产品代码: HSB — Rod, Fixation, Intramedullary And Accessories
批准日期: 2026-06-18
受理日期: 2025-09-23
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: Orthopedic

也可从 FDA 官方下载： K253080.pdf

FDA 官方记录： K253080

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。