FDA 510(k)

赫拉克勒斯縫合釘系統

K 號：K201636 · 2020-08-20

決定日期2020-08-20

產品代碼MBI

諮詢委員會或

決定相當於

器材摘要

Hercules Suture Anchor 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 2020-08-20 under 510(k) number K201636. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Hercules Suture Anchor System?

Hercules Suture Anchor System is a medical device that received FDA 510(k) clearance on 2020-08-20. The listed applicant is In2bones USA, LLC. The 510(k) number is K201636.

When did Hercules Suture Anchor System receive FDA 510(k) clearance?

Hercules Suture Anchor System received FDA 510(k) clearance on 2020-08-20, under 510(k) number K201636.

Who is the listed applicant for Hercules Suture Anchor 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 Suture Anchor System?

The FDA product code for Hercules Suture Anchor System is MBI.

其他以 In2bones USA, LLC 為申請人之記錄

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相關器械（代碼：MBI）

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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