FDA 510(k)

VERTICALE® 三角固定系統

K 號：K223806 · 2023-07-06

決定日期2023-07-06

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

VERTICALE® Triangular Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Silony Medical GmbH. It received FDA 510(k) clearance on 2023-07-06 under 510(k) number K223806. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VERTICALE® Triangular Fixation System?

VERTICALE® Triangular Fixation System is a medical device that received FDA 510(k) clearance on 2023-07-06. The listed applicant is Silony Medical GmbH. The 510(k) number is K223806.

When did VERTICALE® Triangular Fixation System receive FDA 510(k) clearance?

VERTICALE® Triangular Fixation System received FDA 510(k) clearance on 2023-07-06, under 510(k) number K223806.

Who is the listed applicant for VERTICALE® Triangular Fixation System?

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

What is the FDA product code for VERTICALE® Triangular Fixation System?

The FDA product code for VERTICALE® Triangular Fixation System is NKB.

其他以 Silony Medical GmbH 為申請人之記錄

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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相關器械（代碼：NKB）

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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官方來源

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