FDA 510(k)

PL8 髒骨重建板

K 號：K180150 · 2018-08-02

決定日期2018-08-02

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

PL8 Wrist Reconstruction Plate is the device name listed in this FDA 510(k) record. The listed applicant is Citieffe S.R.L.. It received FDA 510(k) clearance on 2018-08-02 under 510(k) number K180150. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PL8 Wrist Reconstruction Plate?

PL8 Wrist Reconstruction Plate is a medical device that received FDA 510(k) clearance on 2018-08-02. The listed applicant is Citieffe S.R.L.. The 510(k) number is K180150.

When did PL8 Wrist Reconstruction Plate receive FDA 510(k) clearance?

PL8 Wrist Reconstruction Plate received FDA 510(k) clearance on 2018-08-02, under 510(k) number K180150.

Who is the listed applicant for PL8 Wrist Reconstruction Plate?

The FDA 510(k) record lists Citieffe S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PL8 Wrist Reconstruction Plate?

The FDA product code for PL8 Wrist Reconstruction Plate is HRS.

其他以 Citieffe S.R.L. 為申請人之記錄

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相關器械（代碼：HRS）

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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