FDA 510(k)

Apex 適合膝關節系統

K 號：K201611 · 2021-04-02

決定日期2021-04-02

產品代碼JWH

諮詢委員會或

決定相當於

器材摘要

Apex 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 2021-04-02 under 510(k) number K201611. 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 Knee System?

Apex Knee System is a medical device that received FDA 510(k) clearance on 2021-04-02. The listed applicant is Omnilife Science. The 510(k) number is K201611.

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

Apex Knee System received FDA 510(k) clearance on 2021-04-02, under 510(k) number K201611.

Who is the listed applicant for Apex 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 Knee System?

The FDA product code for Apex 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。

K172467OMNI ARC 向前傾斜頸部髋关节假体 K171156OMNI Anseris 髋關節頭 K163332Apex 適應膝關節系統

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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