FDA 510(k)

Fusion Compact Navigation System

K号: K153247 · 2016-02-18

决定日期2016-02-18

产品代码PGW

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决定实质等同

器械摘要

Fusion Compact Navigation System is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2016-02-18 under 510(k) number K153247. The device is classified under product code PGW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Fusion Compact Navigation System?

Fusion Compact Navigation System is a medical device that received FDA 510(k) clearance on 2016-02-18. The listed applicant is Medtronic Navigation, Inc.. The 510(k) number is K153247.

When did Fusion Compact Navigation System receive FDA 510(k) clearance?

Fusion Compact Navigation System received FDA 510(k) clearance on 2016-02-18, under 510(k) number K153247.

Who is the listed applicant for Fusion Compact Navigation System?

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

What is the FDA product code for Fusion Compact Navigation System?

The FDA product code for Fusion Compact Navigation System is PGW.

列明Medtronic Navigation, 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。

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相关器械（代码：PGW）

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。

K262235ApexCut™ 自动电磁跟踪刀片（187BL4012EM）；ApexCut™ 自动电磁跟踪刀片（187BL4040EM）；ApexCut™ 自动电磁跟踪刀片（187BL4060EM）；ApexCut™ 自动电磁跟踪刀片（187BL2975EM）；ApexCut™ 自动电磁跟踪刀片（187BL3590EM）；ApexCut™ 自动电磁跟踪刀片（187BL4000LEM）Medtronic Xomed, Inc.K261540Cube 4D 导航系统，VirtuEye ProFiagon GmbH K253395Stealth AXiS™ ENT临床应用Medtronic Navigation, Inc.K243053Navient 图像引导导航系统 (ENT) (955-NC-NC)Claronav K231862TruDi® 导航系统 V3（FG-2000-00）Acclarent, Inc.K223734ENT EMBrainlab AG

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