FDA 510(k)

LinkSympho膝關節系統

K 號：K202924 · 2021-05-13

決定日期2021-05-13

產品代碼JWH

諮詢委員會或

決定相當於

器材摘要

LinkSymphoKnee System is the device name listed in this FDA 510(k) record. The listed applicant is Waldemar Link GmbH & Co. KG. It received FDA 510(k) clearance on 2021-05-13 under 510(k) number K202924. 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 LinkSymphoKnee System?

LinkSymphoKnee System is a medical device that received FDA 510(k) clearance on 2021-05-13. The listed applicant is Waldemar Link GmbH & Co. KG. The 510(k) number is K202924.

When did LinkSymphoKnee System receive FDA 510(k) clearance?

LinkSymphoKnee System received FDA 510(k) clearance on 2021-05-13, under 510(k) number K202924.

Who is the listed applicant for LinkSymphoKnee System?

The FDA 510(k) record lists Waldemar Link GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LinkSymphoKnee System?

The FDA product code for LinkSymphoKnee System is JWH.

其他以 Waldemar Link GmbH & Co. KG 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。

K261009MobileLink 骨盆杯系統 – 40mm ID 插片（各種）K250375Allure骨盆柄和骨髓內插釘 K243927MobileLink 骨盆杯系統 - 自家塗層 K241636MobileLink 骨盆杯系統 - 線路擴展（多個）K231445連結肩部系統 - 反向配置 K222066LINK MobileLink 骨盆杯系統

查看所有 30 項裝置 →

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

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。