FDA 510(k)

SmartFrame OR

K号: K233141 · 2024-01-12

决定日期2024-01-12

产品代码HAW

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决定实质等同

器械摘要

SmartFrame OR is the device name listed in this FDA 510(k) record. The listed applicant is ClearPoint Neuro, Inc.. It received FDA 510(k) clearance on 2024-01-12 under 510(k) number K233141. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SmartFrame OR?

SmartFrame OR is a medical device that received FDA 510(k) clearance on 2024-01-12. The listed applicant is ClearPoint Neuro, Inc.. The 510(k) number is K233141.

When did SmartFrame OR receive FDA 510(k) clearance?

SmartFrame OR received FDA 510(k) clearance on 2024-01-12, under 510(k) number K233141.

Who is the listed applicant for SmartFrame OR?

The FDA 510(k) record lists ClearPoint Neuro, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SmartFrame OR?

The FDA product code for SmartFrame OR is HAW.

列明ClearPoint Neuro, Inc.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。

K243657ClearPoint 系统（软件版本 3.0）K233703骨锚 (NGS-BA-01)K233155ClearPointer 光学导航棒 K233144ClearPoint 骨螺钉标记物 K233243ClearPoint 系统（软件版本 2.2）K232102ClearPoint Array 系统（版本 1.2）

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官方来源

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