FDA 510(k)

Klassic膝關節系統胫骨插板，PS-Max

K 號：K202740 · 2020-10-09

決定日期2020-10-09

產品代碼JWH

諮詢委員會或

決定相當於

器材摘要

Klassic Knee System Tibial Inserts, PS-Max is the device name listed in this FDA 510(k) record. The listed applicant is Total Joint Orthopedics, Inc.. It received FDA 510(k) clearance on 2020-10-09 under 510(k) number K202740. 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 Klassic Knee System Tibial Inserts, PS-Max?

Klassic Knee System Tibial Inserts, PS-Max is a medical device that received FDA 510(k) clearance on 2020-10-09. The listed applicant is Total Joint Orthopedics, Inc.. The 510(k) number is K202740.

When did Klassic Knee System Tibial Inserts, PS-Max receive FDA 510(k) clearance?

Klassic Knee System Tibial Inserts, PS-Max received FDA 510(k) clearance on 2020-10-09, under 510(k) number K202740.

Who is the listed applicant for Klassic Knee System Tibial Inserts, PS-Max?

FDA 510(k) 記錄將 Total Joint Orthopedics, Inc. 列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Klassic Knee System Tibial Inserts, PS-Max?

The FDA product code for Klassic Knee System Tibial Inserts, PS-Max is JWH.

其他以 Total Joint Orthopedics, Inc. 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。

K261734Klassic感染間隔系統 K220483Platform® 髋臼系統 K211877Klassic 適合膝關節系統 K211602Klassic 適合膝關節系統 K183596Klassic膝關節系統 - Klassic膝關節 PS-Post大腿；Klassic膝關節胫骨植入體，PS-Post，標準多聚物；Klassic膝關節胫骨植入體，PS-Post，E-Link多聚物 K190280Klassic 適合膝關節系統 - Sombrero 適合膝蓋標準多聚物，Klassic 適合膝關節系統 - Sombrero 適合膝蓋 E-Link 多聚物

查看所有 12 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。