FDA 510(k)

Eleganz 結合螺釘系統（結合螺釘系統）

K 號：K250251 · 2025-06-13

申請人Dev4

決定日期2025-06-13

產品代碼HWC

諮詢委員會或

決定相當於

器材摘要

Eleganz Fusion Screw System (Fusion Screw System) is the device name listed in this FDA 510(k) record. The listed applicant is Dev4. It received FDA 510(k) clearance on 2025-06-13 under 510(k) number K250251. 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 Eleganz Fusion Screw System (Fusion Screw System)?

Eleganz Fusion Screw System (Fusion Screw System) is a medical device that received FDA 510(k) clearance on 2025-06-13. The listed applicant is Dev4. The 510(k) number is K250251.

When did Eleganz Fusion Screw System (Fusion Screw System) receive FDA 510(k) clearance?

Eleganz Fusion Screw System (Fusion Screw System) received FDA 510(k) clearance on 2025-06-13, under 510(k) number K250251.

Who is the listed applicant for Eleganz Fusion Screw System (Fusion Screw System)?

The FDA 510(k) record lists Dev4 as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Eleganz Fusion Screw System (Fusion Screw System)?

The FDA product code for Eleganz Fusion Screw System (Fusion Screw System) is HWC. This falls under the Cardiovascular category.

其他以 Dev4 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。

K252312Eleganz IM 穿釘系統（IM 穿釘系統）

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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