FDA 510(k)

ネクシス®圧縮ボルト

K番号: K223468 · 2023-08-30

決定日2023-08-30

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

Nexis® compressive screws is the device name listed in this FDA 510(k) record. The listed applicant is Novastep. It received FDA 510(k) clearance on 2023-08-30 under 510(k) number K223468. 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 Nexis® compressive screws?

Nexis® compressive screws is a medical device that received FDA 510(k) clearance on 2023-08-30. The listed applicant is Novastep. The 510(k) number is K223468.

When did Nexis® compressive screws receive FDA 510(k) clearance?

Nexis® compressive screws received FDA 510(k) clearance on 2023-08-30, under 510(k) number K223468.

Who is the listed applicant for Nexis® compressive screws?

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 Nexis® compressive screws?

The FDA product code for Nexis® compressive screws is HWC. This falls under the Cardiovascular category.

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