FDA 510(k)

activL® 新一代儀器設備

K 號：K231769 · 2023-07-13

決定日期2023-07-13

產品代碼QLQ

諮詢委員會或

決定相當於

器材摘要

activL® Next Generation Instrumentation is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap Implants Systems, LLC. It received FDA 510(k) clearance on 2023-07-13 under 510(k) number K231769. The device is classified under product code QLQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the activL® Next Generation Instrumentation?

activL® Next Generation Instrumentation is a medical device that received FDA 510(k) clearance on 2023-07-13. The listed applicant is Aesculap Implants Systems, LLC. The 510(k) number is K231769.

When did activL® Next Generation Instrumentation receive FDA 510(k) clearance?

activL® Next Generation Instrumentation received FDA 510(k) clearance on 2023-07-13, under 510(k) number K231769.

Who is the listed applicant for activL® Next Generation Instrumentation?

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

What is the FDA product code for activL® Next Generation Instrumentation?

The FDA product code for activL® Next Generation Instrumentation is QLQ.

其他以 Aesculap Implants Systems, LLC 為申請人之記錄

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相關器械（代碼：QLQ）

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