FDA 510(k)

DePuy Synthes 2.4mm LCP 直型腕骨板，无菌

K 號：K192327 · 2019-11-07

決定日期2019-11-07

產品代碼HRS

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決定相當於

器材摘要

DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (USA) Products, LLC. It received FDA 510(k) clearance on 2019-11-07 under 510(k) number K192327. 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 2.4mm LCP Straight Wrist Plate, Sterile?

DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile is a medical device that received FDA 510(k) clearance on 2019-11-07. The listed applicant is Synthes (USA) Products, LLC. The 510(k) number is K192327.

When did DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile receive FDA 510(k) clearance?

DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile received FDA 510(k) clearance on 2019-11-07, under 510(k) number K192327.

Who is the listed applicant for DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile?

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

What is the FDA product code for DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile?

The FDA product code for DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile is HRS.

其他以 Synthes (USA) Products, LLC 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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