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FDA 510(k)

GEMINI SL 全膝系統、Endo-Model 膝關節系統，以及配備LINK PorEx (TiNbN) 開發內部塗層的Sled 膝關節系統

K 號：K212742 · 2021-09-16

申請人Waldemar Link GmbH & Co. KG
決定日期2021-09-16
產品代碼JWH
諮詢委員會或
決定相當於

器材摘要

GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coating 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 2021-09-16 under 510(k) number K212742. 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 GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coating?

GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coating is a medical device that received FDA 510(k) clearance on 2021-09-16. The listed applicant is Waldemar Link GmbH & Co. KG. The 510(k) number is K212742.

When did GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coating receive FDA 510(k) clearance?

GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coating received FDA 510(k) clearance on 2021-09-16, under 510(k) number K212742.

Who is the listed applicant for GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coating?

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 GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coating?

The FDA product code for GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coating is JWH.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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。

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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 SAK260063GSPE 分隔器The General Hospital Corporation, d/b/a MassachusettsK262293EVOLUTION 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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