K243665

Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor); Crius PEEK Suture Anchor System (Helicoil Anchor); Crius PEEK Suture Anchor System (Pile Anchor)

510(k) 号: K243665
器械名称: Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor); Crius PEEK Suture Anchor System (Helicoil Anchor); Crius PEEK Suture Anchor System (Pile Anchor)
申请人: ZheJiang Decans Medical Devices Co., Ltd. CN
产品代码: MBI — Fastener, Fixation, Nondegradable, Soft Tissue
批准日期: 2025-01-31
受理日期: 2024-11-27
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 · 0.8 MB · FDA 公有领域文件

也可从 FDA 官方下载： K243665.pdf

FDA 官方记录： K243665

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。