FDA 510(k)

金屬內釘螺釘

K 號：K221090 · 2023-01-10

決定日期2023-01-10

產品代碼HWC

諮詢委員會或

決定相當於

器材摘要

Metal Cannulated Screw 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 2023-01-10 under 510(k) number K221090. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the Metal Cannulated Screw?

Metal Cannulated Screw is a medical device that received FDA 510(k) clearance on 2023-01-10. The listed applicant is Double Medical Technology, Inc.. The 510(k) number is K221090.

When did Metal Cannulated Screw receive FDA 510(k) clearance?

Metal Cannulated Screw received FDA 510(k) clearance on 2023-01-10, under 510(k) number K221090.

Who is the listed applicant for Metal Cannulated Screw?

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 Metal Cannulated Screw?

The FDA product code for Metal Cannulated Screw is HWC. This falls under the Cardiovascular category.

其他以 Double Medical Technology, Inc. 為申請人之記錄

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相關器械（代碼：HWC）

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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