FDA 510(k)

解剖骨板

K 號：K221088 · 2023-01-18

決定日期2023-01-18

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

Anatomic Bone Plate is the device name listed in this FDA 510(k) record. The listed applicant is Double Medical Technology, Inc.. It received FDA 510(k) clearance on 2023-01-18 under 510(k) number K221088. 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 Anatomic Bone Plate?

Anatomic Bone Plate is a medical device that received FDA 510(k) clearance on 2023-01-18. The listed applicant is Double Medical Technology, Inc.. The 510(k) number is K221088.

When did Anatomic Bone Plate receive FDA 510(k) clearance?

Anatomic Bone Plate received FDA 510(k) clearance on 2023-01-18, under 510(k) number K221088.

Who is the listed applicant for Anatomic Bone Plate?

The FDA 510(k) record lists Double Medical Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Anatomic Bone Plate?

The FDA product code for Anatomic Bone Plate is HRS.

其他以 Double Medical Technology, Inc. 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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