FDA 510(k)

NCB植片系統遠端股骨與近端胫骨

K 號：K192217 · 2019-09-13

決定日期2019-09-13

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

NCB Plating System Distal Femur and Proximal Tibia is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer GmbH. It received FDA 510(k) clearance on 2019-09-13 under 510(k) number K192217. 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 NCB Plating System Distal Femur and Proximal Tibia?

NCB Plating System Distal Femur and Proximal Tibia is a medical device that received FDA 510(k) clearance on 2019-09-13. The listed applicant is Zimmer GmbH. The 510(k) number is K192217.

When did NCB Plating System Distal Femur and Proximal Tibia receive FDA 510(k) clearance?

NCB Plating System Distal Femur and Proximal Tibia received FDA 510(k) clearance on 2019-09-13, under 510(k) number K192217.

Who is the listed applicant for NCB Plating System Distal Femur and Proximal Tibia?

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

What is the FDA product code for NCB Plating System Distal Femur and Proximal Tibia?

The FDA product code for NCB Plating System Distal Femur and Proximal Tibia is HRS.

其他以 Zimmer GmbH 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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官方來源

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