K250929

TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate); TriMed Ulnar Osteotomy System (Hex Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Locking Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Lag Screw 3.2mm)

510(k) 号: K250929
器械名称: TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate); TriMed Ulnar Osteotomy System (Hex Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Locking Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Lag Screw 3.2mm)
申请人: TriMed, Inc. CA · US
产品代码: HRS — Plate, Fixation, Bone
批准日期: 2025-06-26
受理日期: 2025-03-28
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 · 0.3 MB · FDA 公有领域文件

也可从 FDA 官方下载： K250929.pdf

FDA 官方记录： K250929

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。