FDA 510(k)

AnyPlus 导航器械系统

K号: K243073 · 2024-12-06

决定日期2024-12-06

产品代码OLO

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决定实质等同

器械摘要

AnyPlus Navigated Instruments System is the device name listed in this FDA 510(k) record. The listed applicant is GS Medical Co., Ltd.. It received FDA 510(k) clearance on 2024-12-06 under 510(k) number K243073. 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 AnyPlus Navigated Instruments System?

AnyPlus Navigated Instruments System is a medical device that received FDA 510(k) clearance on 2024-12-06. The listed applicant is GS Medical Co., Ltd.. The 510(k) number is K243073.

When did AnyPlus Navigated Instruments System receive FDA 510(k) clearance?

AnyPlus Navigated Instruments System received FDA 510(k) clearance on 2024-12-06, under 510(k) number K243073.

Who is the listed applicant for AnyPlus Navigated Instruments System?

FDA 510(k)记录将GS Medical Co., Ltd.列为申请人。这本身并不足以确定设备制造商。

What is the FDA product code for AnyPlus Navigated Instruments System?

The FDA product code for AnyPlus Navigated Instruments System is OLO.

列明GS Medical Co., Ltd.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。

K254260VEGA 颈椎螺钉系统 K241738PYXIS 3D 钛合金颈椎笼系统 K240350AnyPlus II 脊柱固定系统 K231808QUASAR 独立 ACIF 系统 K223868PYXIS 3D 钛合金笼系统 K222041CYGNUS-C 独立 ACIF 系统

查看所有 14 个设备 →

官方来源

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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。