K241435
- 510(k) 号
- K241435
- 器械名称
- Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, co-braid-blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, co-braid-blue
- 申请人
- Smith & Nephew, Inc. MA · US
- 产品代码
- MBI — Fastener, Fixation, Nondegradable, Soft Tissue
- 批准日期
- 2024-06-20
- 受理日期
- 2024-05-21
- 决定
- Substantially Equivalent
- 审查途径
- Special
- 咨询委员会
- Orthopedic
FDA 官方记录: K241435
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。