FDA 510(k)

EMPOWR PS 適合膝關節系統

K 號：K160342 · 2016-05-19

決定日期2016-05-19

產品代碼JWH

諮詢委員會或

決定相當於

器材摘要

EMPOWR PS Knee System 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 2016-05-19 under 510(k) number K160342. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EMPOWR PS Knee System?

EMPOWR PS Knee System is a medical device that received FDA 510(k) clearance on 2016-05-19. The listed applicant is Encore Medical L.P.. The 510(k) number is K160342.

When did EMPOWR PS Knee System receive FDA 510(k) clearance?

EMPOWR PS Knee System received FDA 510(k) clearance on 2016-05-19, under 510(k) number K160342.

Who is the listed applicant for EMPOWR PS Knee System?

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 PS Knee System?

The FDA product code for EMPOWR PS Knee System is JWH.

其他以 Encore Medical L.P. 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。

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相關器械（代碼：JWH）

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。

K262057GMK 扩充設備Medacta International SA K260063GSPE 分隔器The General Hospital Corporation, d/b/a Massachusetts K262293EVOLUTION MPX™ 全膝系統Suzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ 全膝系統修復水泥固定胫骨增強器、樹枝擴展和壓入式樹枝擴展B-One Ortho, Corp.K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.K253961SK膝關節系統Just Medical Devices (Tianjin) Co., Ltd.

官方來源

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