FDA 510(k)

钻头引导器；钻头；脊柱和创伤导航

K号: K240701 · 2024-05-23

决定日期2024-05-23

产品代码OLO

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决定实质等同

器械摘要

Drill Guide; Drill Bit; Spine & Trauma Navigation is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2024-05-23 under 510(k) number K240701. 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 Drill Guide; Drill Bit; Spine & Trauma Navigation?

Drill Guide; Drill Bit; Spine & Trauma Navigation is a medical device that received FDA 510(k) clearance on 2024-05-23. The listed applicant is Brainlab AG. The 510(k) number is K240701.

When did Drill Guide; Drill Bit; Spine & Trauma Navigation receive FDA 510(k) clearance?

Drill Guide; Drill Bit; Spine & Trauma Navigation received FDA 510(k) clearance on 2024-05-23, under 510(k) number K240701.

Who is the listed applicant for Drill Guide; Drill Bit; Spine & Trauma Navigation?

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 Drill Guide; Drill Bit; Spine & Trauma Navigation?

The FDA product code for Drill Guide; Drill Bit; Spine & Trauma Navigation 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。

K252476查看器（5.4）；元素查看器；混合现实查看器；智能布局；元素查看器智能布局 K252562Spine & Trauma Navigation Instruments K243432血管导航 PAD 2.0；血管导航软件 Vascular PAD K243142颅骨4Pi固定装置 K250440RT Elements (4.5); (Elements) 多个脑转移SRS; (Elements) 颅脑SRS; (Elements) 脊柱SRS; (Elements) 颅脑SRS带锥形; (Elements) RT 计划平台; (Elements) 剂量审查; (Elements) 重新治疗审查; Elements 分割 [颅脑，基底神经节，头颈，盆腔，脊柱，胸椎和脊柱，颅外] RT; Elements AI 肿瘤分割 RT; Elements SmartBrush [血管，脊柱] RT; Elements 对象管理 RT K243633Brainlab Elements (7.0)；Brainlab Elements Image Fusion (5.0)；Brainlab Elements Image Fusion Angio (1.0)；Brainlab Elements Contouring (5.0)；Brainlab Elements Fibertracking (3.0)；Brainlab Elements BOLD MRI Mapping (1.0)

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官方来源

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