FDA 510(k)

PROstep™ MIS 5mm フェススクリューシステム

K番号: K221645 · 2023-02-17

決定日2023-02-17

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

PROstep(TM) MIS 5mm Chamfer Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Wright Medical Technology. It received FDA 510(k) clearance on 2023-02-17 under 510(k) number K221645. 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 PROstep(TM) MIS 5mm Chamfer Screw System?

PROstep(TM) MIS 5mm Chamfer Screw System is a medical device that received FDA 510(k) clearance on 2023-02-17. The listed applicant is Wright Medical Technology. The 510(k) number is K221645.

When did PROstep(TM) MIS 5mm Chamfer Screw System receive FDA 510(k) clearance?

PROstep(TM) MIS 5mm Chamfer Screw System received FDA 510(k) clearance on 2023-02-17, under 510(k) number K221645.

Who is the listed applicant for PROstep(TM) MIS 5mm Chamfer Screw System?

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

What is the FDA product code for PROstep(TM) MIS 5mm Chamfer Screw System?

The FDA product code for PROstep(TM) MIS 5mm Chamfer Screw System is HWC. This falls under the Cardiovascular category.

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PROstep™ MIS 5mm フェススクリューシステム

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：HWC）

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