FDA 510(k)

骨骼動態中段肱骨板系統

K 號：K200701 · 2020-05-14

決定日期2020-05-14

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

Skeletal Dynamics Midshaft Humerus Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Skeletal Dynamics, Inc.. It received FDA 510(k) clearance on 2020-05-14 under 510(k) number K200701. 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 Skeletal Dynamics Midshaft Humerus Plating System?

Skeletal Dynamics Midshaft Humerus Plating System is a medical device that received FDA 510(k) clearance on 2020-05-14. The listed applicant is Skeletal Dynamics, Inc.. The 510(k) number is K200701.

When did Skeletal Dynamics Midshaft Humerus Plating System receive FDA 510(k) clearance?

Skeletal Dynamics Midshaft Humerus Plating System received FDA 510(k) clearance on 2020-05-14, under 510(k) number K200701.

Who is the listed applicant for Skeletal Dynamics Midshaft Humerus Plating System?

FDA 510(k) 記錄將 Skeletal Dynamics, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Skeletal Dynamics Midshaft Humerus Plating System?

The FDA product code for Skeletal Dynamics Midshaft Humerus Plating System is HRS.

其他以 Skeletal Dynamics, Inc. 為申請人之記錄

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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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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