FDA 510(k)

長板修復股骨柄

K 號：K243021 · 2025-08-07

決定日期2025-08-07

產品代碼LZO

諮詢委員會或

決定相當於

器材摘要

Longboard Revision Hip Stem is the device name listed in this FDA 510(k) record. The listed applicant is Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2025-08-07 under 510(k) number K243021. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Longboard Revision Hip Stem?

Longboard Revision Hip Stem is a medical device that received FDA 510(k) clearance on 2025-08-07. The listed applicant is Signature Orthopaedics Pty, Ltd.. The 510(k) number is K243021.

When did Longboard Revision Hip Stem receive FDA 510(k) clearance?

Longboard Revision Hip Stem received FDA 510(k) clearance on 2025-08-07, under 510(k) number K243021.

Who is the listed applicant for Longboard Revision Hip Stem?

The FDA 510(k) record lists Signature Orthopaedics Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Longboard Revision Hip Stem?

The FDA product code for Longboard Revision Hip Stem is LZO.

其他以 Signature Orthopaedics Pty, Ltd. 為申請人之記錄

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相關器械（代碼：LZO）

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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