FDA 510(k)

Apex 適應膝關節系統

K 號：K163332 · 2017-04-26

決定日期2017-04-26

產品代碼JWH

諮詢委員會或

決定相當於

器材摘要

Apex Revision Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Omnilife Science. It received FDA 510(k) clearance on 2017-04-26 under 510(k) number K163332. 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 Apex Revision Knee System?

Apex Revision Knee System is a medical device that received FDA 510(k) clearance on 2017-04-26. The listed applicant is Omnilife Science. The 510(k) number is K163332.

When did Apex Revision Knee System receive FDA 510(k) clearance?

Apex Revision Knee System received FDA 510(k) clearance on 2017-04-26, under 510(k) number K163332.

Who is the listed applicant for Apex Revision Knee System?

The FDA 510(k) record lists Omnilife Science as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Apex Revision Knee System?

The FDA product code for Apex Revision Knee System is JWH.

其他以 Omnilife Science 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。

K201611Apex 適合膝關節系統 K172467OMNI ARC 向前傾斜頸部髋关节假体 K171156OMNI Anseris 髋關節頭

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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