FDA 510(k)

TheRay 股骨柄頸部可穿著式與無頸部設計

K 號：K241875 · 2024-09-13

決定日期2024-09-13

產品代碼MEH

諮詢委員會或

決定相當於

器材摘要

TheRay Collared and Collarless Femoral Stem is the device name listed in this FDA 510(k) record. The listed applicant is Nextstep Arthropedix. It received FDA 510(k) clearance on 2024-09-13 under 510(k) number K241875. 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 TheRay Collared and Collarless Femoral Stem?

TheRay Collared and Collarless Femoral Stem is a medical device that received FDA 510(k) clearance on 2024-09-13. The listed applicant is Nextstep Arthropedix. The 510(k) number is K241875.

When did TheRay Collared and Collarless Femoral Stem receive FDA 510(k) clearance?

TheRay Collared and Collarless Femoral Stem received FDA 510(k) clearance on 2024-09-13, under 510(k) number K241875.

Who is the listed applicant for TheRay Collared and Collarless Femoral Stem?

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

What is the FDA product code for TheRay Collared and Collarless Femoral Stem?

The FDA product code for TheRay Collared and Collarless Femoral Stem is MEH.

其他以 Nextstep Arthropedix 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。

K242410NextStep 骨科總膝系統

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.K251052Trivicta® 髋關節柄Ortho Development Corp.K242315解決模組化修復股骨柄United Orthopedic Corporation K243839Alteon® HA Femoral StemsExactech, Inc.

官方來源

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