FDA 510(k)

arcad® 2.0 Duo & Quadro 骨折固定圧縮釘

K番号: K230724 · 2023-12-04

決定日2023-12-04

製品コードJDR

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

arcad® 2.0 Duo & Quadro osteosynthesis compressive staples is the device name listed in this FDA 510(k) record. The listed applicant is Novastep. It received FDA 510(k) clearance on 2023-12-04 under 510(k) number K230724. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the arcad® 2.0 Duo & Quadro osteosynthesis compressive staples?

arcad® 2.0 Duo & Quadro osteosynthesis compressive staples is a medical device that received FDA 510(k) clearance on 2023-12-04. The listed applicant is Novastep. The 510(k) number is K230724.

When did arcad® 2.0 Duo & Quadro osteosynthesis compressive staples receive FDA 510(k) clearance?

arcad® 2.0 Duo & Quadro osteosynthesis compressive staples received FDA 510(k) clearance on 2023-12-04, under 510(k) number K230724.

Who is the listed applicant for arcad® 2.0 Duo & Quadro osteosynthesis compressive staples?

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

What is the FDA product code for arcad® 2.0 Duo & Quadro osteosynthesis compressive staples?

The FDA product code for arcad® 2.0 Duo & Quadro osteosynthesis compressive staples is JDR.

申請者としてNovastepを記載するその他の記録

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