FDA 510(k)

MetaFore 小螺絲系統

K 號：K250536 · 2025-10-08

決定日期2025-10-08

產品代碼HWC

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決定相當於

器材摘要

MetaFore Small Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Extremity Medical, LLC. It received FDA 510(k) clearance on 2025-10-08 under 510(k) number K250536. 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 MetaFore Small Screw System?

MetaFore Small Screw System is a medical device that received FDA 510(k) clearance on 2025-10-08. The listed applicant is Extremity Medical, LLC. The 510(k) number is K250536.

When did MetaFore Small Screw System receive FDA 510(k) clearance?

MetaFore Small Screw System received FDA 510(k) clearance on 2025-10-08, under 510(k) number K250536.

Who is the listed applicant for MetaFore Small Screw System?

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

What is the FDA product code for MetaFore Small Screw System?

The FDA product code for MetaFore Small Screw System is HWC. This falls under the Cardiovascular category.

其他以 Extremity Medical, LLC 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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