FDA 510(k)

Huvex間棘固定系統

K 號：K162849 · 2017-02-16

決定日期2017-02-16

產品代碼PEK

諮詢委員會或

決定相當於

器材摘要

Huvex Interspinous Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Dio Medical Co., Ltd.. It received FDA 510(k) clearance on 2017-02-16 under 510(k) number K162849. The device is classified under product code PEK. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Huvex Interspinous Fixation System?

Huvex Interspinous Fixation System is a medical device that received FDA 510(k) clearance on 2017-02-16. The listed applicant is Dio Medical Co., Ltd.. The 510(k) number is K162849.

When did Huvex Interspinous Fixation System receive FDA 510(k) clearance?

Huvex Interspinous Fixation System received FDA 510(k) clearance on 2017-02-16, under 510(k) number K162849.

Who is the listed applicant for Huvex Interspinous Fixation System?

The FDA 510(k) record lists Dio Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Huvex Interspinous Fixation System?

The FDA product code for Huvex Interspinous Fixation System is PEK.

其他以 Dio Medical Co., Ltd. 為申請人之記錄

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K162220DIO醫療IVA（ACIF、DLIF、PLIF、TLIF及ALIF）籠

相關器械（代碼：PEK）

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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