FDA 510(k)

Spine & Trauma Navigation Instruments

K号: K252562 · 2025-09-12

决定日期2025-09-12

产品代码OLO

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决定实质等同

器械摘要

Spine & Trauma Navigation Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2025-09-12 under 510(k) number K252562. 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 Spine & Trauma Navigation Instruments?

Spine & Trauma Navigation Instruments is a medical device that received FDA 510(k) clearance on 2025-09-12. The listed applicant is Brainlab AG. The 510(k) number is K252562.

When did Spine & Trauma Navigation Instruments receive FDA 510(k) clearance?

Spine & Trauma Navigation Instruments received FDA 510(k) clearance on 2025-09-12, under 510(k) number K252562.

Who is the listed applicant for Spine & Trauma Navigation Instruments?

The FDA 510(k) record lists Brainlab AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Spine & Trauma Navigation Instruments?

The FDA product code for Spine & Trauma Navigation Instruments is OLO.

列明Brainlab AG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。

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