FDA 510(k)

Q 导航系统；Mako 脊柱系统；

K号: K241517 · 2024-08-27

决定日期2024-08-27

产品代码OLO

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决定实质等同

器械摘要

Q Guidance System; Mako Spine System; is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Leibinger GmbH & Co KG. It received FDA 510(k) clearance on 2024-08-27 under 510(k) number K241517. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Q Guidance System; Mako Spine System;?

Q Guidance System; Mako Spine System; is a medical device that received FDA 510(k) clearance on 2024-08-27. The listed applicant is Stryker Leibinger GmbH & Co KG. The 510(k) number is K241517.

When did Q Guidance System; Mako Spine System; receive FDA 510(k) clearance?

Q Guidance System; Mako Spine System; received FDA 510(k) clearance on 2024-08-27, under 510(k) number K241517.

Who is the listed applicant for Q Guidance System; Mako Spine System;?

The FDA 510(k) record lists Stryker Leibinger GmbH & Co KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Q Guidance System; Mako Spine System;?

The FDA product code for Q Guidance System; Mako Spine System; is OLO.

列明Stryker Leibinger GmbH & Co KG为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K261054肋板系统 K254233MEDPOR 定制植入套件 K253623Spine Guidance 5.4 软件包；Spine Guidance 5.4 升级；Spine Guidance 5.4 更新；Spine Guidance 5.4 软件启用；Spine Guidance 5.4 销售演示；Q 钻孔跟踪器；NavLock 适配器；Elite Q 连接器；Elite 切割附件；Maestro Air 电机 K252871Spine Guidance 5.3 软件包；Q 内置体工具；Elite Q 连接器；Elite 切割附件 K243491胸骨钢板扩张器 K241171Spine Guidance 软件包（版本 5.1）；综合手术室设备（CORE）2 控制台；CORE Q 脚踏开关；PI Drive 2 电机；Elite Q 连接器和切割附件

查看所有 19 个设备 →

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。