FDA 510(k)

赫拉克勒斯關節間植入系統

K 號：K220260 · 2022-03-31

決定日期2022-03-31

產品代碼HTN

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決定相當於

器材摘要

Hercules Syndesmosis Implant System is the device name listed in this FDA 510(k) record. The listed applicant is In2bones USA, LLC. It received FDA 510(k) clearance on 2022-03-31 under 510(k) number K220260. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Hercules Syndesmosis Implant System?

Hercules Syndesmosis Implant System is a medical device that received FDA 510(k) clearance on 2022-03-31. The listed applicant is In2bones USA, LLC. The 510(k) number is K220260.

When did Hercules Syndesmosis Implant System receive FDA 510(k) clearance?

Hercules Syndesmosis Implant System received FDA 510(k) clearance on 2022-03-31, under 510(k) number K220260.

Who is the listed applicant for Hercules Syndesmosis Implant System?

The FDA 510(k) record lists In2bones USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hercules Syndesmosis Implant System?

The FDA product code for Hercules Syndesmosis Implant System is HTN.

其他以 In2bones USA, LLC 為申請人之記錄

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相關器械（代碼：HTN）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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