FDA 510(k)

FasTouch 可吸收固定系統

K 號：K181668 · 2019-03-13

決定日期2019-03-13

產品代碼GDW

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

FasTouch Absorbable Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Via Surgical , Ltd.. It received FDA 510(k) clearance on 2019-03-13 under 510(k) number K181668. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FasTouch Absorbable Fixation System?

FasTouch Absorbable Fixation System is a medical device that received FDA 510(k) clearance on 2019-03-13. The listed applicant is Via Surgical , Ltd.. The 510(k) number is K181668.

When did FasTouch Absorbable Fixation System receive FDA 510(k) clearance?

FasTouch Absorbable Fixation System received FDA 510(k) clearance on 2019-03-13, under 510(k) number K181668.

Who is the listed applicant for FasTouch Absorbable Fixation System?

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

What is the FDA product code for FasTouch Absorbable Fixation System?

The FDA product code for FasTouch Absorbable Fixation System is GDW.

其他以 Via Surgical , Ltd. 為申請人之記錄

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K203117組織膠帶設備 K162252FasTouch固定系統

相關器械（代碼：GDW）

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。

官方來源

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