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FDA 510(k)

INBONE™ 全踝系統、INFINITY™ 全踝系統及INVISION™ 全踝更換系統

K 號：K193067 · 2020-06-08

申請人Wrightmedicaltechnologyinc
決定日期2020-06-08
產品代碼HSN
諮詢委員會或
決定相當於

器材摘要

The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2020-06-08 under 510(k) number K193067. The device is classified under product code HSN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System?

The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System is a medical device that received FDA 510(k) clearance on 2020-06-08. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K193067.

When did The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System receive FDA 510(k) clearance?

The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System received FDA 510(k) clearance on 2020-06-08, under 510(k) number K193067.

Who is the listed applicant for The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System?

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

What is the FDA product code for The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System?

The FDA product code for The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System is HSN.

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 Wrightmedicaltechnologyinc 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：HSN）

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。

K253159預言環繞外科計劃系統Wright Medical Technology, Inc. (Stryker)K252454金諾斯全腳踝系統Restor3DK250037Incompass 全踝系統Wright Medical Technology, Inc. (Stryker)K250641APEX 3D 全踝關節置換系統Paragon 28, Inc.K240475後曼系列 H2 全腳踝系統Vilex, LLCK241999預言外科計劃系統Wright Medical Technology, Inc. (Stryker)

官方來源

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