FDA 510(k)

Elos® 髓內釘固定系統

K 號：K201147 · 2021-07-19

決定日期2021-07-19

產品代碼HSB

諮詢委員會或

決定相當於

器材摘要

Elos® Intramedullary Nailing System is the device name listed in this FDA 510(k) record. The listed applicant is Intrauma S.P.A. It received FDA 510(k) clearance on 2021-07-19 under 510(k) number K201147. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Elos® Intramedullary Nailing System?

Elos® Intramedullary Nailing System is a medical device that received FDA 510(k) clearance on 2021-07-19. The listed applicant is Intrauma S.P.A. The 510(k) number is K201147.

When did Elos® Intramedullary Nailing System receive FDA 510(k) clearance?

Elos® Intramedullary Nailing System received FDA 510(k) clearance on 2021-07-19, under 510(k) number K201147.

Who is the listed applicant for Elos® Intramedullary Nailing System?

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

What is the FDA product code for Elos® Intramedullary Nailing System?

The FDA product code for Elos® Intramedullary Nailing System is HSB.

其他以 Intrauma S.P.A 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。

K252959WRISTAR 多軸遠端桡骨套件 K230623KITE 遠端腓骨套件

相關器械（代碼：HSB）

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。

K261345兒童釘針平台髋骨OrthoPediatrics Corp.K261481Pangea 髋骨重建系統Stryker GmbH K253080AND 医療股骨釘系統 (PFNA01); AND 医療股骨釘系統 (PFNA02)Suzhou and Science & Technology Development Corp.K261651Precice™ Max 系統及 Precice™ 腳踝挽救系統NuVasive Specialized Orthopedics K253155富麗金屬可鎖定內骨髓釘系統Beijing Fule Science & Technology Development Co., Ltd.K253046HERA 開合式硬脊釘系統ZheJiang Decans Medical Devices Co., Ltd.

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。