FDA 510(k)

SFプッシュインアンカー

K番号: K240288 · 2024-04-01

決定日2024-04-01

製品コードMAI

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

SF Push- in Anchor is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Fusion Technologies GmbH. It received FDA 510(k) clearance on 2024-04-01 under 510(k) number K240288. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the SF Push- in Anchor?

SF Push- in Anchor is a medical device that received FDA 510(k) clearance on 2024-04-01. The listed applicant is Surgical Fusion Technologies GmbH. The 510(k) number is K240288.

When did SF Push- in Anchor receive FDA 510(k) clearance?

SF Push- in Anchor received FDA 510(k) clearance on 2024-04-01, under 510(k) number K240288.

Who is the listed applicant for SF Push- in Anchor?

The FDA 510(k) record lists Surgical Fusion Technologies GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SF Push- in Anchor?

The FDA product code for SF Push- in Anchor is MAI.

申請者としてSurgical Fusion Technologies GmbHを記載するその他の記録

K260294SFプッシュインアンカー

公式ソース

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