FDA 510(k)

ClearPoint 骨螺钉标记物

K号: K233144 · 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

ClearPoint Bone Screw Fiducials 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 K233144. 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 ClearPoint Bone Screw Fiducials?

ClearPoint Bone Screw Fiducials 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 K233144.

When did ClearPoint Bone Screw Fiducials receive FDA 510(k) clearance?

ClearPoint Bone Screw Fiducials received FDA 510(k) clearance on 2024-01-12, under 510(k) number K233144.

Who is the listed applicant for ClearPoint Bone Screw Fiducials?

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 ClearPoint Bone Screw Fiducials?

The FDA product code for ClearPoint Bone Screw Fiducials 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 K233141SmartFrame OR K233243ClearPoint 系统（软件版本 2.2）K232102ClearPoint Array 系统（版本 1.2）

查看所有 11 个设备 →

官方来源

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