FDA 510(k)

X-Twist Biocomposite Suture Anchor

K番号: K232513 · 2023-09-18

決定日2023-09-18

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

X-Twist Biocomposite Suture Anchor is the device name listed in this FDA 510(k) record. The listed applicant is Parcus Medical. It received FDA 510(k) clearance on 2023-09-18 under 510(k) number K232513. 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 X-Twist Biocomposite Suture Anchor?

X-Twist Biocomposite Suture Anchor is a medical device that received FDA 510(k) clearance on 2023-09-18. The listed applicant is Parcus Medical. The 510(k) number is K232513.

When did X-Twist Biocomposite Suture Anchor receive FDA 510(k) clearance?

X-Twist Biocomposite Suture Anchor received FDA 510(k) clearance on 2023-09-18, under 510(k) number K232513.

Who is the listed applicant for X-Twist Biocomposite Suture Anchor?

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

What is the FDA product code for X-Twist Biocomposite Suture Anchor?

The FDA product code for X-Twist Biocomposite Suture Anchor is MAI.

申請者としてParcus Medicalを記載するその他の記録

K170877パルカスSLiKフィックスボルト K170327パルカスSLiKアンカース

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