FDA 510(k)

Aesculap(R) 器官系统 (AIS) S4 导航工具

K号: K153700 · 2016-07-08

决定日期2016-07-08

产品代码OLO

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决定实质等同

器械摘要

Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap Implant Systems, LLC. It received FDA 510(k) clearance on 2016-07-08 under 510(k) number K153700. 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 Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments?

Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments is a medical device that received FDA 510(k) clearance on 2016-07-08. The listed applicant is Aesculap Implant Systems, LLC. The 510(k) number is K153700.

When did Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments receive FDA 510(k) clearance?

Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments received FDA 510(k) clearance on 2016-07-08, under 510(k) number K153700.

Who is the listed applicant for Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments?

The FDA 510(k) record lists Aesculap Implant Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments?

The FDA product code for Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments is OLO.

列明Aesculap Implant Systems, LLC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。

K213871Ennovate 颈椎和枕骨系统 K210963ENNOVATE 脊柱系统 K180433ENNOVATE®K162134ENNOVATE 脊柱系统 K153396Aesculap OrthoPilot 新一代

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