FDA 510(k)

TRILEAP 鍍膜系統

K 號：K253178 · 2026-01-06

決定日期2026-01-06

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

TRILEAP Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Crossroads Extremity Systems. It received FDA 510(k) clearance on 2026-01-06 under 510(k) number K253178. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TRILEAP Plating System?

TRILEAP Plating System is a medical device that received FDA 510(k) clearance on 2026-01-06. The listed applicant is Crossroads Extremity Systems. The 510(k) number is K253178.

When did TRILEAP Plating System receive FDA 510(k) clearance?

TRILEAP Plating System received FDA 510(k) clearance on 2026-01-06, under 510(k) number K253178.

Who is the listed applicant for TRILEAP Plating System?

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

What is the FDA product code for TRILEAP Plating System?

The FDA product code for TRILEAP Plating System is HRS.

其他以 Crossroads Extremity Systems 為申請人之記錄

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K241050橋路模組式托盤系統 K230591TriLEAP植板系統

相關器械（代碼：HRS）

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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