K253623

Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air Motor

510(k) 号: K253623
器械名称: Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air Motor
申请人: Stryker Leibinger GmbH & Co KG DE
产品代码: OLO — Orthopedic Stereotaxic Instrument
批准日期: 2026-02-19
受理日期: 2025-11-18
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 · 0.5 MB · FDA 公有领域文件

也可从 FDA 官方下载： K253623.pdf

FDA 官方记录： K253623

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。