K240662

Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedicle Preparation Instruments; Q S2AI Drills; Q Handles; Consolidated Operating Room Equipment (CORE) 2 Console; Electric System 6 Dual Trigger Rotary Handpiece

510(k) 号: K240662
器械名称: Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedicle Preparation Instruments; Q S2AI Drills; Q Handles; Consolidated Operating Room Equipment (CORE) 2 Console; Electric System 6 Dual Trigger Rotary Handpiece
申请人: Stryker Leibinger GmbH & Co KG DE
产品代码: OLO — Orthopedic Stereotaxic Instrument
批准日期: 2024-06-06
受理日期: 2024-03-08
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: Neurology

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： K240662.pdf

FDA 官方记录： K240662

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。