FDA 510(k)

Parcus SLiK 固定螺釘

K 號：K170877 · 2017-06-02

決定日期2017-06-02

產品代碼MBI

諮詢委員會或

決定相當於

器材摘要

Parcus SLiK Fix Screw is the device name listed in this FDA 510(k) record. The listed applicant is Parcus Medical. It received FDA 510(k) clearance on 2017-06-02 under 510(k) number K170877. 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 Parcus SLiK Fix Screw?

Parcus SLiK Fix Screw is a medical device that received FDA 510(k) clearance on 2017-06-02. The listed applicant is Parcus Medical. The 510(k) number is K170877.

When did Parcus SLiK Fix Screw receive FDA 510(k) clearance?

Parcus SLiK Fix Screw received FDA 510(k) clearance on 2017-06-02, under 510(k) number K170877.

Who is the listed applicant for Parcus SLiK Fix Screw?

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

What is the FDA product code for Parcus SLiK Fix Screw?

The FDA product code for Parcus SLiK Fix Screw is MBI.

其他以 Parcus Medical 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：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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官方來源

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