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FDA 510(k)

EMPOWR 髋臼內襯擴充器®

K 號:K251833 · 2025-11-12

決定日期2025-11-12
產品代碼LPH
諮詢委員會或
決定相當於

器材摘要

EMPOWR Acetabular® Liner Extension is the device name listed in this FDA 510(k) record. The listed applicant is Encore Medical L.P.. It received FDA 510(k) clearance on 2025-11-12 under 510(k) number K251833. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EMPOWR Acetabular® Liner Extension?

EMPOWR Acetabular® Liner Extension is a medical device that received FDA 510(k) clearance on 2025-11-12. The listed applicant is Encore Medical L.P.. The 510(k) number is K251833.

When did EMPOWR Acetabular® Liner Extension receive FDA 510(k) clearance?

EMPOWR Acetabular® Liner Extension received FDA 510(k) clearance on 2025-11-12, under 510(k) number K251833.

Who is the listed applicant for EMPOWR Acetabular® Liner Extension?

The FDA 510(k) record lists Encore Medical L.P. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMPOWR Acetabular® Liner Extension?

The FDA product code for EMPOWR Acetabular® Liner Extension is LPH.

相關臨床試驗

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其他以 Encore Medical L.P. 為申請人之記錄

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相關器械(代碼:LPH)

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。

官方來源

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