FDA 510(k)

OptiFix AT 機能性固定システム（可動技術付き） – 30本の締め具、OptiFix AT 機能性固定システム（可動技術付き） – 15本の締め具

K番号: K191287 · 2019-07-16

決定日2019-07-16

製品コードGDW

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners is the device name listed in this FDA 510(k) record. The listed applicant is Davol Inc., Subsidiary of C.R. Bard. It received FDA 510(k) clearance on 2019-07-16 under 510(k) number K191287. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners?

OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners is a medical device that received FDA 510(k) clearance on 2019-07-16. The listed applicant is Davol Inc., Subsidiary of C.R. Bard. The 510(k) number is K191287.

When did OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners receive FDA 510(k) clearance?

OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners received FDA 510(k) clearance on 2019-07-16, under 510(k) number K191287.

Who is the listed applicant for OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners?

The FDA 510(k) record lists Davol Inc., Subsidiary of C.R. Bard as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners?

The FDA product code for OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners is GDW.

公式ソース

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OptiFix AT 機能性固定システム（可動技術付き） – 30本の締め具、OptiFix AT 機能性固定システム（可動技術付き） – 15本の締め具

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：GDW）

公式ソース