FDA 510(k)

Akros Scruture Anchor LisFranc Repair Kit

K番号: K200361 · 2020-04-06

決定日2020-04-06

製品コードHTN

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OR [翻訳] OR 注：原文が具体的な内容を含んでいないため、翻訳は単なる「OR」のままです。

決定大幅同等

医療機器の概要

Akros Scruture Anchor LisFranc Repair Kit is the device name listed in this FDA 510(k) record. The listed applicant is Akros Medical. It received FDA 510(k) clearance on 2020-04-06 under 510(k) number K200361. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Akros Scruture Anchor LisFranc Repair Kit?

Akros Scruture Anchor LisFranc Repair Kit is a medical device that received FDA 510(k) clearance on 2020-04-06. The listed applicant is Akros Medical. The 510(k) number is K200361.

When did Akros Scruture Anchor LisFranc Repair Kit receive FDA 510(k) clearance?

Akros Scruture Anchor LisFranc Repair Kit received FDA 510(k) clearance on 2020-04-06, under 510(k) number K200361.

Who is the listed applicant for Akros Scruture Anchor LisFranc Repair Kit?

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

What is the FDA product code for Akros Scruture Anchor LisFranc Repair Kit?

The FDA product code for Akros Scruture Anchor LisFranc Repair Kit is HTN.

申請者としてAkros Medicalを記載するその他の記録

K173550Akros FibuLink™ Syndesmosis Repair Kit K162805Akros Fibulink Syndesmosis Repair Kit

公式ソース

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