FDA 510(k)

Thorecon™ 固定系統

K 號：K173579 · 2018-02-12

決定日期2018-02-12

產品代碼JDQ

諮詢委員會或

決定相當於

器材摘要

Thorecon™ Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is A & E Medical Corporation. It received FDA 510(k) clearance on 2018-02-12 under 510(k) number K173579. The device is classified under product code JDQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Thorecon™ Fixation System?

Thorecon™ Fixation System is a medical device that received FDA 510(k) clearance on 2018-02-12. The listed applicant is A & E Medical Corporation. The 510(k) number is K173579.

When did Thorecon™ Fixation System receive FDA 510(k) clearance?

Thorecon™ Fixation System received FDA 510(k) clearance on 2018-02-12, under 510(k) number K173579.

Who is the listed applicant for Thorecon™ Fixation System?

The FDA 510(k) record lists A & E Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Thorecon™ Fixation System?

The FDA product code for Thorecon™ Fixation System is JDQ.

其他以 A & E Medical Corporation 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。

K193479胸骨電纜系統 K181607Thorecon 強固固定系統 K180582胸骨電纜系統

相關器械（代碼：JDQ）

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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