FDA 510(k)

專家 - 柔性關節固定系統

K 號：K242311 · 2024-11-01

申請人GM Dos Reis Industria e Comercio Ltda.

決定日期2024-11-01

產品代碼HTN

諮詢委員會或

決定相當於

器材摘要

EXPERT - Flexible Joint Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is GM Dos Reis Industria e Comercio Ltda.. It received FDA 510(k) clearance on 2024-11-01 under 510(k) number K242311. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EXPERT - Flexible Joint Fixation System?

EXPERT - Flexible Joint Fixation System is a medical device that received FDA 510(k) clearance on 2024-11-01. The listed applicant is GM Dos Reis Industria e Comercio Ltda.. The 510(k) number is K242311.

When did EXPERT - Flexible Joint Fixation System receive FDA 510(k) clearance?

EXPERT - Flexible Joint Fixation System received FDA 510(k) clearance on 2024-11-01, under 510(k) number K242311.

Who is the listed applicant for EXPERT - Flexible Joint Fixation System?

FDA 510(k) 記錄將 GM Dos Reis Industria e Comercio Ltda. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for EXPERT - Flexible Joint Fixation System?

The FDA product code for EXPERT - Flexible Joint Fixation System is HTN.

其他以 GM Dos Reis Industria e Comercio Ltda. 為申請人之記錄

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相關器械（代碼：HTN）

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。

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官方來源

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