FDA 510(k)

Corin 三適合 TS 臀部設備

K 號：K153772 · 2016-03-31

決定日期2016-03-31

產品代碼MEH

諮詢委員會或

決定相當於

器材摘要

Corin TriFit TS Hip is the device name listed in this FDA 510(k) record. The listed applicant is Corin U.S.A. Limited. It received FDA 510(k) clearance on 2016-03-31 under 510(k) number K153772. The device is classified under product code MEH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Corin TriFit TS Hip?

Corin TriFit TS Hip is a medical device that received FDA 510(k) clearance on 2016-03-31. The listed applicant is Corin U.S.A. Limited. The 510(k) number is K153772.

When did Corin TriFit TS Hip receive FDA 510(k) clearance?

Corin TriFit TS Hip received FDA 510(k) clearance on 2016-03-31, under 510(k) number K153772.

Who is the listed applicant for Corin TriFit TS Hip?

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

What is the FDA product code for Corin TriFit TS Hip?

The FDA product code for Corin TriFit TS Hip is MEH.

其他以 Corin U.S.A. Limited 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。

K242744Trinity EVO 骨盆殼 K241808ApolloHipX (THR.SS.0001)K241472象納髋關節置入體 K241570統一全膝系統 K240875Unity膝關節 PS-C 胫骨插板 K231172ApolloKnee

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相關器械（代碼：MEH）

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。

K261576象納髋關節置入體Corin, Ltd.K250375Allure骨盆柄和骨髓內插釘Waldemar Link GmbH & Co. KG K251166Mfinity 髋關系統Medacta International S.A.K251052Trivicta® 髋關節柄Ortho Development Corp.K242315解決模組化修復股骨柄United Orthopedic Corporation K243839Alteon® HA Femoral StemsExactech, Inc.

官方來源

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