FDA 510(k)

Fixoneバイオコンポジット干渉スクリュー

K番号: K193497 · 2021-01-05

決定日2021-01-05

製品コードHWC

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

Fixone Biocomposite Interference Screw is the device name listed in this FDA 510(k) record. The listed applicant is Aju Pharm Co., Ltd.. It received FDA 510(k) clearance on 2021-01-05 under 510(k) number K193497. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

よくある質問

What is the Fixone Biocomposite Interference Screw?

Fixone Biocomposite Interference Screw is a medical device that received FDA 510(k) clearance on 2021-01-05. The listed applicant is Aju Pharm Co., Ltd.. The 510(k) number is K193497.

When did Fixone Biocomposite Interference Screw receive FDA 510(k) clearance?

Fixone Biocomposite Interference Screw received FDA 510(k) clearance on 2021-01-05, under 510(k) number K193497.

Who is the listed applicant for Fixone Biocomposite Interference Screw?

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

What is the FDA product code for Fixone Biocomposite Interference Screw?

The FDA product code for Fixone Biocomposite Interference Screw is HWC. This falls under the Cardiovascular category.

申請者としてAju Pharm Co., Ltd.を記載するその他の記録

K233601Fixone メニスクリペア K230892Fixoneバイオコンポジットアンカー K222423Fixone 全缝合アンカー K203523Fixoneハイブリッドノットレスアンカー K192709Fixone 全缝合アンカー K192484Fixoneバイオコンポジットアンカー

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公式ソース

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