FDA 510(k)

Freedom(R) - TiNbN 鍍層膝關節

K 號：K200912 · 2020-11-18

決定日期2020-11-18

產品代碼JWH

諮詢委員會或

決定相當於

器材摘要

Freedom(R) - TiNbN Coated Knee is the device name listed in this FDA 510(k) record. The listed applicant is Maxx Orthopedics, Inc.. It received FDA 510(k) clearance on 2020-11-18 under 510(k) number K200912. 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 Freedom(R) - TiNbN Coated Knee?

Freedom(R) - TiNbN Coated Knee is a medical device that received FDA 510(k) clearance on 2020-11-18. The listed applicant is Maxx Orthopedics, Inc.. The 510(k) number is K200912.

When did Freedom(R) - TiNbN Coated Knee receive FDA 510(k) clearance?

Freedom(R) - TiNbN Coated Knee received FDA 510(k) clearance on 2020-11-18, under 510(k) number K200912.

Who is the listed applicant for Freedom(R) - TiNbN Coated Knee?

FDA 510(k) 記錄將 Maxx 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 Freedom(R) - TiNbN Coated Knee?

The FDA product code for Freedom(R) - TiNbN Coated Knee is JWH.

其他以 Maxx 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。

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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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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。