FDA 510(k)

EcoFit® 髋關節系統

K 號：K203420 · 2021-02-03

決定日期2021-02-03

產品代碼LZO

諮詢委員會或

決定相當於

器材摘要

EcoFit® Hip System is the device name listed in this FDA 510(k) record. The listed applicant is Implantcast GmbH. It received FDA 510(k) clearance on 2021-02-03 under 510(k) number K203420. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EcoFit® Hip System?

EcoFit® Hip System is a medical device that received FDA 510(k) clearance on 2021-02-03. The listed applicant is Implantcast GmbH. The 510(k) number is K203420.

When did EcoFit® Hip System receive FDA 510(k) clearance?

EcoFit® Hip System received FDA 510(k) clearance on 2021-02-03, under 510(k) number K203420.

Who is the listed applicant for EcoFit® Hip System?

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

What is the FDA product code for EcoFit® Hip System?

The FDA product code for EcoFit® Hip System is LZO.

其他以 Implantcast GmbH 為申請人之記錄

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相關器械（代碼：LZO）

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。

K260173M-Vizion 髋關節更換系統擴充版Medacta International S.A.K253948動力骨盂杯系統United Orthopedic Corporation K261009MobileLink 骨盆杯系統 – 40mm ID 插片（各種）Waldemar Link GmbH & Co. KG K260831Z1 髋關節系統Zimmer, Inc.K260182Avenir® Müller 植入物；Avenir Complete™ 髋關節系統Zimmer, Inc.K260037植入式醫療設備包裝系統更新Implantcast GmbH

官方來源

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