FDA 510(k)

CoNextions TR 軟骨修復系統

K 號：K203855 · 2022-04-22

決定日期2022-04-22

產品代碼GAQ

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

CoNextions TR Tendon Repair System is the device name listed in this FDA 510(k) record. The listed applicant is Conextions Medical. It received FDA 510(k) clearance on 2022-04-22 under 510(k) number K203855. The device is classified under product code GAQ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CoNextions TR Tendon Repair System?

CoNextions TR Tendon Repair System is a medical device that received FDA 510(k) clearance on 2022-04-22. The listed applicant is Conextions Medical. The 510(k) number is K203855.

When did CoNextions TR Tendon Repair System receive FDA 510(k) clearance?

CoNextions TR Tendon Repair System received FDA 510(k) clearance on 2022-04-22, under 510(k) number K203855.

Who is the listed applicant for CoNextions TR Tendon Repair System?

The FDA 510(k) record lists Conextions Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CoNextions TR Tendon Repair System?

The FDA product code for CoNextions TR Tendon Repair System is GAQ.

其他以 Conextions Medical 為申請人之記錄

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官方來源

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