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FDA 510(k)

DePuy Synthes 2.7mm 直立板和 2.7mm 适配板(模組化迷你骨片 LCP 系統)

K 號:K211051 · 2021-06-02

申請人DePuy Synthes
決定日期2021-06-02
產品代碼HRS
諮詢委員會或
決定相當於

器材摘要

DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System) is the device name listed in this FDA 510(k) record. The listed applicant is DePuy Synthes. It received FDA 510(k) clearance on 2021-06-02 under 510(k) number K211051. 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 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)?

DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System) is a medical device that received FDA 510(k) clearance on 2021-06-02. The listed applicant is DePuy Synthes. The 510(k) number is K211051.

When did DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System) receive FDA 510(k) clearance?

DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System) received FDA 510(k) clearance on 2021-06-02, under 510(k) number K211051.

Who is the listed applicant for DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)?

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 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)?

The FDA product code for DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System) 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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