FDA 510(k)

金諾斯全腳踝系統

K 號：K242868 · 2024-10-18

決定日期2024-10-18

產品代碼HSN

諮詢委員會或

決定相當於

器材摘要

Kinos Total Ankle System is the device name listed in this FDA 510(k) record. The listed applicant is Restor3D. It received FDA 510(k) clearance on 2024-10-18 under 510(k) number K242868. 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 Kinos Total Ankle System?

Kinos Total Ankle System is a medical device that received FDA 510(k) clearance on 2024-10-18. The listed applicant is Restor3D. The 510(k) number is K242868.

When did Kinos Total Ankle System receive FDA 510(k) clearance?

Kinos Total Ankle System received FDA 510(k) clearance on 2024-10-18, under 510(k) number K242868.

Who is the listed applicant for Kinos Total Ankle System?

The FDA 510(k) record lists Restor3D as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kinos Total Ankle System?

The FDA product code for Kinos Total Ankle System is HSN.

其他以 Restor3D 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。

K260556Veritas肩部系統 K253992Veritas逆向全肩關節系統 K252454金諾斯全腳踝系統 K243643restor3d 過全肩關節置换系統 K241482金諾斯全腳踝系統 K234087restor3d TIDAL 腰椎間融合系統

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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Restor3D K250037Incompass 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, LLC K241999預言外科計劃系統Wright Medical Technology, Inc. (Stryker)

官方來源

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