FDA 510(k)

EMPOWR雙向移動金屬內襯，EMPOWR雙向移動多層環承

K 號：K203557 · 2021-02-10

決定日期2021-02-10

產品代碼LPH

諮詢委員會或

決定相當於

器材摘要

EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing 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 2021-02-10 under 510(k) number K203557. 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 Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing?

EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing is a medical device that received FDA 510(k) clearance on 2021-02-10. The listed applicant is Encore Medical L.P.. The 510(k) number is K203557.

When did EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing receive FDA 510(k) clearance?

EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing received FDA 510(k) clearance on 2021-02-10, under 510(k) number K203557.

Who is the listed applicant for EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing?

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 Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing?

The FDA product code for EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing is LPH.

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。

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