FDA 510(k)

Klassic 適合膝關節系統

K 號：K211602 · 2021-07-23

決定日期2021-07-23

產品代碼JWH

諮詢委員會或

決定相當於

器材摘要

Klassic Knee System 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 2021-07-23 under 510(k) number K211602. 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?

Klassic Knee System is a medical device that received FDA 510(k) clearance on 2021-07-23. The listed applicant is Total Joint Orthopedics, Inc.. The 510(k) number is K211602.

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

Klassic Knee System received FDA 510(k) clearance on 2021-07-23, under 510(k) number K211602.

Who is the listed applicant for Klassic Knee System?

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?

The FDA product code for Klassic Knee System 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 K202740Klassic膝關節系統胫骨插板，PS-Max 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

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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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