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FDA 510(k)

DePuy Synthes 2.4/2.7mm VA LCP雙柱桡骨遠端掌側板,超長版

K 號:K163046 · 2017-02-09

申請人DePuy Synthes
決定日期2017-02-09
產品代碼HRS
諮詢委員會或
決定相當於

器材摘要

DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long is the device name listed in this FDA 510(k) record. The listed applicant is DePuy Synthes. It received FDA 510(k) clearance on 2017-02-09 under 510(k) number K163046. 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 DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long?

DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long is a medical device that received FDA 510(k) clearance on 2017-02-09. The listed applicant is DePuy Synthes. The 510(k) number is K163046.

When did DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long receive FDA 510(k) clearance?

DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long received FDA 510(k) clearance on 2017-02-09, under 510(k) number K163046.

Who is the listed applicant for DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long?

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

What is the FDA product code for DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long?

The FDA product code for DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long is HRS.

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其他以 DePuy Synthes 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。

官方來源

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