FDA 510(k)

Trivicta® 髋關節柄

K 號：K251052 · 2025-05-22

決定日期2025-05-22

產品代碼MEH

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決定相當於

器材摘要

Trivicta® Hip Stem is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Development Corp.. It received FDA 510(k) clearance on 2025-05-22 under 510(k) number K251052. The device is classified under product code MEH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Trivicta® Hip Stem?

Trivicta® Hip Stem is a medical device that received FDA 510(k) clearance on 2025-05-22. The listed applicant is Ortho Development Corp.. The 510(k) number is K251052.

When did Trivicta® Hip Stem receive FDA 510(k) clearance?

Trivicta® Hip Stem received FDA 510(k) clearance on 2025-05-22, under 510(k) number K251052.

Who is the listed applicant for Trivicta® Hip Stem?

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

What is the FDA product code for Trivicta® Hip Stem?

The FDA product code for Trivicta® Hip Stem is MEH.

其他以 Ortho Development Corp. 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。

K253161平衡膝關節系統 TriMax 多孔股骨組件 K242984BKS修復系統 K242833萊格德® 骨盆杯 K233758Trivicta™ 髋關節柄

相關器械（代碼：MEH）

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。

K261576象納髋關節置入體Corin, Ltd.K250375Allure骨盆柄和骨髓內插釘Waldemar Link GmbH & Co. KG K251166Mfinity 髋關系統Medacta International S.A.K242315解決模組化修復股骨柄United Orthopedic Corporation K243839Alteon® HA Femoral StemsExactech, Inc.K243162世界線材Signature Orthopaedics Pty, Ltd.

官方來源

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