FDA 510(k)

APEX 3D 全踝關節置換系統

K 號：K250641 · 2025-05-01

決定日期2025-05-01

產品代碼HSN

諮詢委員會或

決定相當於

器材摘要

APEX 3D Total Ankle Replacement System is the device name listed in this FDA 510(k) record. The listed applicant is Paragon 28, Inc.. It received FDA 510(k) clearance on 2025-05-01 under 510(k) number K250641. The device is classified under product code HSN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the APEX 3D Total Ankle Replacement System?

APEX 3D Total Ankle Replacement System is a medical device that received FDA 510(k) clearance on 2025-05-01. The listed applicant is Paragon 28, Inc.. The 510(k) number is K250641.

When did APEX 3D Total Ankle Replacement System receive FDA 510(k) clearance?

APEX 3D Total Ankle Replacement System received FDA 510(k) clearance on 2025-05-01, under 510(k) number K250641.

Who is the listed applicant for APEX 3D Total Ankle Replacement System?

FDA 510(k) 記錄將 Paragon 28, 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 APEX 3D Total Ankle Replacement System?

The FDA product code for APEX 3D Total Ankle Replacement System is HSN.

其他以 Paragon 28, Inc. 為申請人之記錄

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相關器械（代碼：HSN）

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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