FDA 510(k)

金屬骨釘

K 號：K220921 · 2022-12-12

決定日期2022-12-12

產品代碼HWC

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器材摘要

Metal Bone 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 2022-12-12 under 510(k) number K220921. 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 Bone Screw?

Metal Bone Screw is a medical device that received FDA 510(k) clearance on 2022-12-12. The listed applicant is Double Medical Technology, Inc.. The 510(k) number is K220921.

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

Metal Bone Screw received FDA 510(k) clearance on 2022-12-12, under 510(k) number K220921.

Who is the listed applicant for Metal Bone 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 Bone Screw?

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

其他以 Double Medical Technology, 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：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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