FDA 510(k)

Evolve AP杯，世界鳍杯，世界G-Zero Liner及奇數球頭

K 號：K252824 · 2026-03-12

決定日期2026-03-12

產品代碼JDI

諮詢委員會或

決定相當於

器材摘要

Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head 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 2026-03-12 under 510(k) number K252824. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head?

Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head is a medical device that received FDA 510(k) clearance on 2026-03-12. The listed applicant is Signature Orthopaedics Pty, Ltd.. The 510(k) number is K252824.

When did Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head receive FDA 510(k) clearance?

Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head received FDA 510(k) clearance on 2026-03-12, under 510(k) number K252824.

Who is the listed applicant for Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head?

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 Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head?

The FDA product code for Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head is JDI.

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

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相關器械（代碼：JDI）

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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