K252898

Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper

510(k) 号: K252898
器械名称: Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper
申请人: Howmedica Osteonics Corp., Dba Stryker Orthopaedics NJ · US
产品代码: KRO — Prosthesis, Knee, Femorotibial, Constrained, Cemente
批准日期: 2025-12-15
受理日期: 2025-09-11
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 · 1.2 MB · FDA 公有领域文件

也可从 FDA 官方下载： K252898.pdf

FDA 官方记录： K252898

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。