FDA 510(k)

Infinity-Lock 3, Infinity-Lock 5

K 號：K171680 · 2017-06-30

決定日期2017-06-30

產品代碼GAT

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

Infinity-Lock 3, Infinity-Lock 5 is the device name listed in this FDA 510(k) record. The listed applicant is Xiros, Ltd.. It received FDA 510(k) clearance on 2017-06-30 under 510(k) number K171680. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Infinity-Lock 3, Infinity-Lock 5?

Infinity-Lock 3, Infinity-Lock 5 is a medical device that received FDA 510(k) clearance on 2017-06-30. The listed applicant is Xiros, Ltd.. The 510(k) number is K171680.

When did Infinity-Lock 3, Infinity-Lock 5 receive FDA 510(k) clearance?

Infinity-Lock 3, Infinity-Lock 5 received FDA 510(k) clearance on 2017-06-30, under 510(k) number K171680.

Who is the listed applicant for Infinity-Lock 3, Infinity-Lock 5?

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

What is the FDA product code for Infinity-Lock 3, Infinity-Lock 5?

The FDA product code for Infinity-Lock 3, Infinity-Lock 5 is GAT.

其他以 Xiros, Ltd. 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。

查看所有 8 項裝置 →

相關器械（代碼：GAT）

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。

K253910釘線 - 緝合針線及膠帶GM Dos Reis Industria e Comercio Ltda.K261021EasyWhip 家族Winter Innovations, Inc.K260775聚乙烯；聚乙烯融合；聚乙烯正骨膠帶™Teleflex Medical, LLC K254275超縫全綠延伸線Threadstone, LLC K254188半月板VersaflexGM Dos Reis Industria e Comercio Ltda.K253145預縫合腱Rti Surgical, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。