FDA 510(k)

手部創傷螺釘系統

K 號：K230908 · 2023-04-28

決定日期2023-04-28

產品代碼HWC

諮詢委員會或

決定相當於

器材摘要

Hand Trauma Threaded Nail 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 2023-04-28 under 510(k) number K230908. 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 Hand Trauma Threaded Nail System?

Hand Trauma Threaded Nail System is a medical device that received FDA 510(k) clearance on 2023-04-28. The listed applicant is Skeletal Dynamics, Inc.. The 510(k) number is K230908.

When did Hand Trauma Threaded Nail System receive FDA 510(k) clearance?

Hand Trauma Threaded Nail System received FDA 510(k) clearance on 2023-04-28, under 510(k) number K230908.

Who is the listed applicant for Hand Trauma Threaded Nail 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 Hand Trauma Threaded Nail System?

The FDA product code for Hand Trauma Threaded Nail System is HWC. This falls under the Cardiovascular category.

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：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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