FDA 510(k)

平衡膝®系統 TriMax PS Plus 胫骨插件

K 號：K233093 · 2023-10-25

決定日期2023-10-25

產品代碼JWH

諮詢委員會或

決定相當於

器材摘要

Balanced Knee® System TriMax PS Plus Tibial Insert is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Development Corporation. It received FDA 510(k) clearance on 2023-10-25 under 510(k) number K233093. 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 Balanced Knee® System TriMax PS Plus Tibial Insert?

Balanced Knee® System TriMax PS Plus Tibial Insert is a medical device that received FDA 510(k) clearance on 2023-10-25. The listed applicant is Ortho Development Corporation. The 510(k) number is K233093.

When did Balanced Knee® System TriMax PS Plus Tibial Insert receive FDA 510(k) clearance?

Balanced Knee® System TriMax PS Plus Tibial Insert received FDA 510(k) clearance on 2023-10-25, under 510(k) number K233093.

Who is the listed applicant for Balanced Knee® System TriMax PS Plus Tibial Insert?

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

What is the FDA product code for Balanced Knee® System TriMax PS Plus Tibial Insert?

The FDA product code for Balanced Knee® System TriMax PS Plus Tibial Insert is JWH.

其他以 Ortho Development Corporation 為申請人之記錄

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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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