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FDA 510(k)

金諾斯軟骨全腳踝系統

K 號：K192778 · 2020-06-30

申請人Kinos Medical
決定日期2020-06-30
產品代碼HSN
諮詢委員會或
決定相當於

器材摘要

Kinos Axiom Total Ankle System is the device name listed in this FDA 510(k) record. The listed applicant is Kinos Medical. It received FDA 510(k) clearance on 2020-06-30 under 510(k) number K192778. 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 Axiom Total Ankle System?

Kinos Axiom Total Ankle System is a medical device that received FDA 510(k) clearance on 2020-06-30. The listed applicant is Kinos Medical. The 510(k) number is K192778.

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

Kinos Axiom Total Ankle System received FDA 510(k) clearance on 2020-06-30, under 510(k) number K192778.

Who is the listed applicant for Kinos Axiom Total Ankle System?

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

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

The FDA product code for Kinos Axiom Total Ankle 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

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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