FDA 510(k)

Integra 萨爾托全腳踝系統

K 號：K182878 · 2018-12-18

決定日期2018-12-18

產品代碼HSN

諮詢委員會或

決定相當於

器材摘要

Integra Salto Total Ankle System is the device name listed in this FDA 510(k) record. The listed applicant is Ascension Orthopedics. It received FDA 510(k) clearance on 2018-12-18 under 510(k) number K182878. 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 Integra Salto Total Ankle System?

Integra Salto Total Ankle System is a medical device that received FDA 510(k) clearance on 2018-12-18. The listed applicant is Ascension Orthopedics. The 510(k) number is K182878.

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

Integra Salto Total Ankle System received FDA 510(k) clearance on 2018-12-18, under 510(k) number K182878.

Who is the listed applicant for Integra Salto Total Ankle System?

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

What is the FDA product code for Integra Salto Total Ankle System?

The FDA product code for Integra Salto Total Ankle System is HSN.

其他以 Ascension Orthopedics 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。

K162153Integra® CAPTURE™ 螺釘系統 & Integra® Ti6® 內固定系統 K160830整合外固定系統

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

在 FDA 資料庫中查看 →

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。